This page shows what was measured, who it was measured in, and what that does not settle.
What Tislelizumab does in the body
Tislelizumab-jsgr binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
From the FDA-approved label: Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Tislelizumab-jsgr decreased tumor growth in xenograft models and a human PD-1 transgenic mouse model.
Why people take it. Unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 0KVO411B3N · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
No statement of the main limit is recorded.
The four opening statements run to 118 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Protein
A protein is a folded chain your body builds to do a specific job.
A picture of it, and where the picture fails
A protein is like a tool bent into one shape for one task.
Where that stops being true. A tool keeps its shape. A protein can change shape and stop working.
What people get wrong. Protein in food and a protein in the body are related but not the same thing.
A polymer of amino acids folded into a defined structure that determines its function.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
calculated cut-off value for serum ferritin in the diagnosis of irAE
✗ The study did not show it
Who was studied
NCT06702566
How many people
1500
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Overall Survival in PD-L1 Positive Participants
✗ The study did not show it
Who was studied
NCT03777657
How many people
997
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Incidence of Adverse Events (AEs)
✗ The study did not show it
Who was studied
NCT04170283
How many people
955
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Progression-free survival (PFS) by BICR
✗ The study did not show it
Who was studied
NCT05152147
How many people
920
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Overall Survival (OS) in All Participants (Co-primary Endpoint)
✗ The study did not show it
Who was studied
NCT03358875
How many people
805
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Progression Free Survival (PFS)
✗ The study did not show it
Who was studied
NCT06206733
How many people
780
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.14 registered measures of this kind. 4 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
part b progression free survival
overall survival in all
overall survival in the intent to treat analysis set
progression free survival
overall survival in pd l1 positive
overall survival
1 year progression free survival rate
progression free survival by investigator
disease free survival rate
rate of progression free survival
and 4 more.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (26)
part b objective response rate
overall response rate
adverse events
phase 2 overall response rate
objective response rate
phase 1 number of dose limiting toxicities
adverse events and serious adverse events
severity of adverse events and serious adverse events
dose interruptions and reductions
dose intensity
experiencing adverse events
frequency of dose interruptions
frequency of dose reductions
completely adhering to 3 cycles of short term fasting
who develop unacceptable fasting related toxicity
aes/saes
clinical complete response rate
pathological complete response
part 1 number of dose limiting toxicities
part 2 objective response rate
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 24 days
Read from the label, which states: “Elimination The tislelizumab-jsgr total clearance is 0.153 L/day (29.5%) and the terminal half-life (t ½ ) is 24 days (31%).”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of TEVIMBRA have not been established in pediatric patients.”
US prescribing information · 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a · read 2026-08-30
On older people, the label states: “TEVIMBRA as a Single Agent Of the 255 patients who were treated with TEVIMBRA for previously treated unresectable or metastatic ESCC in the clinical study RATIONALE-302, 98 (38%) were 65 years and older and 13 (5%) were 75 years and older.”
US prescribing information · 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action, TEVIMBRA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .”
US prescribing information · 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of tislelizumab-jsgr in human milk, or its effects on the breastfed child or on milk production.”
US prescribing information · 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Still being tested
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Intravenous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S4, S7.
No source is stored against this line.
What is in the pack
Sold as injection, solution, concentrate, given by the intravenous route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Tislelizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 386 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
vomiting — 47 reaction mentions
nausea — 46 reaction mentions
diarrhoea — 43 reaction mentions
anaemia — 41 reaction mentions
myelosuppression — 39 reaction mentions
rash — 39 reaction mentions
thrombocytopenia — 34 reaction mentions
hypothyroidism — 33 reaction mentions
decreased appetite — 32 reaction mentions
fatigue — 32 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Intravenous
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
6 products list this as an active ingredient in the United States drug directory. 6 of them contain it and nothing else.
FDA National Drug Code directory · 77657-010 · read 2026-08-29
They are sold as injection, solution, concentrate and liquid, taken intravenous.
FDA National Drug Code directory · 77657-010 · read 2026-08-29
The regulator's established pharmacologic class for it is programmed death receptor-1 blocking antibody [epc] and programmed death receptor-1-directed antibody interactions [moa].
FDA National Drug Code directory · 77657-010 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a · read 2026-08-29
TEVIMBRA is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 100 mg/10 mL (10 mg/mL) and 150 mg/15 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial., recorded as fda label in effect 2026-05-22 in the United States.
US prescribing information · 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Tislelizumab studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Tislelizumab are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Where else this substance is registered
FDA substance identifier (UNII)
0KVO411B3N
CAS registry number
1858168-59-8
WHO international nonproprietary name list entry
10553
EMA substance identifier
100000178119
DrugBank
DB14922
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S3, S4, S7.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
The earliest marketing start date recorded for a listed product is 20230501.
FDA National Drug Code directory · 77657-010 · read 2026-08-29
What is missing or unclear◇Read from sources, not yet reviewed
What to learn next
Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
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Recorded evidence blocks (11)
Q2
What did Tislelizumab's largest trial (997 people) and its longest (15 years) measure?
997 people in Tislelizumab's largest registered study, 15 years in its longest registered window, measuring Safety Run-in Sub-study: Serum Concentration of Tislelizumab. ClinicalTrials.gov · 2026-09-01
297 phase2, 95 phase1, 61 phase3, 13 na or unstated, 6 na, 5 phase4, 3 early phase1; NCT06563245; 2039-11-15; no ageing endpoint recorded. Last human test completed 2026, NCT05909904.
Interpretation These counts include studies where Tislelizumab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
297
phase1
95
phase3
61
na or unstated
13
na
6
phase4
5
2 more recorded rows
early phase1
3
Last recorded human testNCT05909904
2026-07-23
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Tislelizumab shown biomarker?
"Study Was Terminated Early"; 30 of 433 registered studies
Show the evidence
Trial
NCT03379259
terminated; "Study Was Terminated Early"
NCT03745222
terminated; "BeiGene and Celgene Corporation terminated the parties' global collaboration for the compound, pending the acquisition of Celgene by Bristol Myers Squibb"
NCT04261439
terminated; "Sponsor's decision and not due to any safety concerns"
NCT04294160
terminated; "The decision of early termination was made due to business reasons, and was not based on any safety concerns for any of the treatment combinations."
NCT04363801
terminated; "experimental treatment will not be more efficacious than its comparator in the primary endpoint of PFS"
NCT04425070
terminated; "Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study"
14 further recorded trials
NCT04486391
terminated; "Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern."
NCT04577963
terminated; "At the time of study termination, both fruquintinib and tislelizumab are commercially available in the United States."
NCT04746924
terminated; "This decision was conducted by the sponsor based on lack of efficacy and not driven by safety concerns."
NCT04866017
terminated; "This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the ociperlimab program."
NCT04906382
terminated; "Sponsor reorganization"
NCT04921358
terminated; "Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study."
NCT04924413
terminated; "Slow enrollment"
NCT04952753
terminated; "The study was terminated early due to the halt of NIS793 treatment and urgent safety measures issued in July and August 2023, respectively, as continued evaluation of Standard of Care alone will not support the trial's purpose."
NCT05176925
terminated; "The trial was terminated per sponsor recommendation"
NCT05461794
terminated; "Due to modification of company strategy."
NCT05494762
terminated; "Sponsor decision"
NCT05564338
withdrawn; "Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern or the request from any health authority worldwide."
NCT05581719
terminated; "Sponsor decision"
NCT05614453
withdrawn; "BeiGene has withdrawn their support owing to sitravatinib supply concerns. Mirati is ceasing further development of sitravatinib owing to the negative results of the SAPPHIRE trial which used sitravatinib in 2nd line met NSCLC setting."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Tislelizumab used Tislelizumab 200mg — over how long?
5 recorded entries; human; also "Tislelizumab 200mg", "Tislelizumab 400mg", "Tislelizumab 200 mg"
Show the evidence
human
NCT04363801
Tislelizumab 200mg
NCT04363801
Tislelizumab 400mg
NCT05244837
Tislelizumab 200 mg
NCT06446726
Tislelizumab, fixed dose of 200 mg
NCT06722183
Tislelizumab (i.v. 200mg)
recorded 2026-09-01 · last checked 2026-09-04
Q6
Tislelizumab's half-life is 24 days — which schedules were studied?
24 days, the half-life Tislelizumab's label states. openfda-label · 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a · 2026-08-30
Show the evidence
half life
24 days; Elimination The tislelizumab-jsgr total clearance is 0.153 L/day (29.5%) and the terminal half-life (t ½ ) is 24 days (31%).
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 1 year disease free survival, 1 year progression free survival rate and 1 year recurrence free survival rate did Tislelizumab's trials measure?
1 year disease free survival, 1 year progression free survival rate and 1 year recurrence free survival rate lead 40 outcome terms across Tislelizumab's trials. ClinicalTrials.gov · 2026-09-01
overall survival in all, overall survival in the intent to treat analysis set, adverse events, phase 2 overall response rate, progression free survival and overall survival in pd l1 positive follow.
Show the evidence
part b objective response rate
1
part b progression free survival
1
overall response rate
1
overall survival in all
1
overall survival in the intent to treat analysis set
1
adverse events
1
14 more recorded rows
phase 2 overall response rate
1
progression free survival
1
overall survival in pd l1 positive
1
overall survival
1
objective response rate
1
phase 1 number of dose limiting toxicities
1
adverse events and serious adverse events
1
severity of adverse events and serious adverse events
1
dose interruptions and reductions
1
dose intensity
1
experiencing adverse events
1
frequency of dose interruptions
1
frequency of dose reductions
1
completely adhering to 3 cycles of short term fasting
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Tislelizumab's 228 ongoing trials reports first?
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1; Overall survival (OS) in the Intent to Treat (ITT) set; latest 2039-11-15
Show the evidence
Trial
NCT03736889
"Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors"; n 200; "Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1"; 2027-09
NCT03967977
"Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma"; n 420; "Overall survival (OS) in the Intent to Treat (ITT) set"; 2027-10-21
NCT04170283
"A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib"; n 955; "Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)"; 2026-12-31
NCT04271956
"Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment With or Without Sonrotoclax for Patients With Richter Transformation"; n 83; "Overall response rate (ORR) after induction therapy according to the refined Lugano Classification (Cheson et al, 2016)"; 2027-08
NCT04379635
"Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)"; n 453; "Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set"; 2027-03-31
NCT04387084
"Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy"; n 10; "Percentage of patients completely adhering to 3 cycles of short term fasting (STF) (9 days of fasting)"; 2027-08-12
14 further recorded trials
NCT04443543
"An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer"; n 222; "clinical complete response rate"; 2026-12-31
NCT04501523
"A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC"; n 460; "5 years Disease free survival(DFS)"; 2032-08
NCT04615143
"Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCC"; n 80; "Disease-free survival rate"; 2027-12-01
NCT04699188
"Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation"; n 344; "Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment"; 2027-01-25
NCT04802876
"Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors"; n 184; "Overall Response rate (ORR) (Cohort 3)"; 2027-03-31
NCT04837859
"Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma"; n 120; "Progression Free Survival"; 2028-05
NCT04954781
"TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma"; n 25; "Objective Response Rate (ORR)"; 2025-07-15
NCT04973306
"Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC"; n 176; "Pathological response rate(pCR)"; 2027-07
NCT05057845
"Cryoablation Combined with Tislelizumab Plus Lenvatinib As Second-line or Later Therapy in Advanced Hepatocellular Carcinoma"; n 25; "Objective Response Rate (ORR)"; 2026-09-20
NCT05152147
"A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers"; n 920; "Progression-free survival (PFS) by BICR"; 2027-09-30
NCT05167071
"HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study"; n 53; "Part 1: DLT"; 2026-06-30
NCT05189457
"First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer"; n 32; "Overall Survival"; 2028-07
NCT05211232
"Neoadjuvant and Adjuvant Tislelizumab for Nasopharyngeal Carcinoma"; n 450; "Complete Response"; 2028-06-02
NCT05231850
"A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI."; n 70; "Primary End point: Disease Free survival [ Time Frame: 3 years ]"; 2027-09-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Tislelizumab could settle lifespan?
NCT05468242 measures Progression free survival, reading out 2024-12-30.
67 open trials; n 116; "Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy"
Show the evidence
Trial
NCT05468242
"Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy"; n 116; "Progression free survival"; 2024-12-30
NCT06323382
"Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma"; n 240; "Progression-Free-Survival (PFS)"; 2025-12-30
NCT06333561
"HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma"; n 300; "Overall survival"; 2025-12-30
NCT05520619
"Combination of Tislelizumab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-002)"; n 114; "Progression-free survival"; 2026-07-31
NCT05990127
"A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer"; n 642; "Overall Survival(OS)"; 2026-11-28
NCT06056336
"Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma"; n 73; "2-year disease-free survival in non-pCR patients"; 2026-12-31
14 further recorded trials
NCT06118658
"Chemotherapy Sequential Tislelizumab After Radical Resection in Patients With dMMR/MSI-H or POLE/POLD1 Mutations"; n 30; "1-year disease-free survival based on RECIST v1.1 criteria (1-year DFS rate)"; 2026-12-31
NCT06536868
"Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC"; n 40; "Progression-free Survival (PFS)"; 2026-12-31
NCT05515315
"Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma"; n 93; "progression free survival"; 2027-05-31
NCT06420440
"Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model"; n 160; "Median event-free survival (EFS)"; 2027-05-31
NCT06414915
"Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation"; n 29; "Progression-Free Survival (PFS)"; 2027-06-01
NCT06009861
"Neoadjuvant Tislelizumab Plus Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer (NeoSPOT)"; n 110; "Rate of Event free survival (EFS) at 2 years"; 2027-06-30
NCT06749886
"An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting"; n 22; "progress free survival"; 2027-06-30
NCT06951841
"Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction"; n 31; "Progression-free survival (PFS)"; 2027-06-30
NCT05919030
"A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma"; n 155; "Progression-Free Survival (PFS)"; 2027-07-01
NCT05231850
"A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI."; n 70; "Primary End point: Disease Free survival [ Time Frame: 3 years ]"; 2027-09-01
NCT05152147
"A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers"; n 920; "Progression-free survival (PFS) by BICR"; 2027-09-30
NCT03967977
"Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma"; n 420; "Overall survival (OS) in the Intent to Treat (ITT) set"; 2027-10-21
NCT06914687
"Efficacy of Tirellizumab Combined With Oral, Intravenous and Abdominal Chemotherapy in Peritoneal Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma"; n 30; "One year overall survival"; 2027-11-01
NCT04615143
"Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCC"; n 80; "Disease-free survival rate"; 2027-12-01
Q10
Which 13 trials of Tislelizumab posted no result?
Posted no result
13 of 13 completed trials
Registrations
NCT03469557, NCT03432598, NCT05809336, NCT04539444, NCT04627012 and NCT04672330, and 7 more
Completion dates
oldest 2020-08-19; newest 2024-08-20
Show the evidence
Trial
NCT03469557
2020-08-19
NCT03432598
2020-12-21
NCT05809336
2022-10-31
NCT04539444
2023-03-31
NCT04627012
2023-07-01
NCT04672330
2023-11-25
7 further recorded trials
NCT04310943
2023-12-01
NCT04570410
2024-04-15
NCT05303090
2024-04-23
NCT05223088
2024-04-30
NCT05807542
2024-04-30
NCT05517330
2024-07-31
NCT05086627
2024-08-20
Q11
At the median, Tislelizumab's trials enrolled 53 people — anything larger?
Median enrolment
53
Largest enrolment
997
Registered trials counted
433
Q12
What do 386 spontaneous reports say about Tislelizumab — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Tislelizumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 386 reaction mentions were counted: vomiting 47; nausea 46; diarrhoea 43; anaemia 41. open-targets-adr · CHEMBL4297840 · 2026-06-24
Show the evidence
vomiting
47
nausea
46
diarrhoea
43
anaemia
41
myelosuppression
39
rash
39
4 more recorded rows
thrombocytopenia
34
hypothyroidism
33
decreased appetite
32
fatigue
32
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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