A Phase 2 interventional study of Tislelizumab and Paclitaxel in HPV-unrelated Head and Neck Squamous Cell Carcinoma, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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Among 16 studies testing tislelizumab in Squamous Cell Carcinoma of Head and Neck — 8 open to participants now, 13 under way, none of them phase 3. tislelizumab · Squamous Cell Carcinoma of Head and Neck.
Among the 16 studies testing tislelizumab in Squamous Cell Carcinoma of Head and Neck, this one is the 5th largest by planned enrollment, is the only one that started in 2026, is one of 12 in phase 2, reaches primary completion later than 12 of the 12 other live ones, and was the 16th registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →8 of the 16 studies testing tislelizumab in Squamous Cell Carcinoma of Head and Neck are open now, in 2 countries. Recruiting first, the newest first:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Sites in China
Ages 18+
Beijing Tongren Hospital · Sites in China
Ages 18+
Weijia Fang, MD · Sites in China
Ages 18–75
University of Chicago · Sites in United States
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–65
By country, each count listing its studies:
tislelizumab: first FDA approval 2024 (TEVIMBRA), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 15
First in 2018; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 104 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 41 across the 16 interventional studies. Of the 2 that completed or were terminated, 1 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 16 have an industry lead sponsor. The 10 most frequent:
Fudan University is the lead sponsor of 1,317 studies on the registry; 645 are open to participants now.
10 studies in Squamous Cell Carcinoma of Head and Neck by Fudan University: 7 open now, 7 under way, 1 of them phase 3. Of 2 finished, 0 (0%) have results posted.
Among the 10 studies in Squamous Cell Carcinoma of Head and Neck by Fudan University, this one is the 2nd largest by planned enrollment, is one of 2 that started in 2026, is one of 7 in phase 2, and was the 9th registered.
Fudan University’s Squamous Cell Carcinoma of Head and Neck studies by the year they started, since 2009.
3 of the studies testing tislelizumab in Squamous Cell Carcinoma of Head and Neck that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06725498Beijing Tongren HospitalIntra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC | 2026-11-30 |
| NCT06978829Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityCetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC | 2027-03-31 |
| NCT07010120West China HospitalA Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head and Neck Squamous Cell Carcinoma | 2027-05-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 16 studies testing tislelizumab in Squamous Cell Carcinoma of Head and Neck, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Fudan University’s 10 in Squamous Cell Carcinoma of Head and Neck:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to evaluate if adding chemotherapy and immunotherapy as induction treatment prior to definitive chemoradiotherapy could improve the outcomes of locally advanced HPV-negative head and neck squamous cell that are not amenable to surgery. The study aims to answer:
This multicenter, prospective, open-label, phase II randomized controlled clinical trial plans to enroll 104 treatment naïve participants with locally advanced (III-IVB by UICC/AJCC 8th), unresectable or inoperable HPV-negative head and neck squamous cell carcinoma (HNSCC). Patients will be stratified by primary tumor site (oropharynx vs. non-oropharynx) and randomly assigned (1:1) to one of two treatment arms: (1) Arm A (Experimental): Induction phase, three cycles of tislelizumab plus paclitaxel and cisplatin; Concurrent chemoradiotherapy (CCRT) phase, definitive radiotherapy concurrent with two cycles of cisplatin; Adjuvant phase, 13 cycles of tislelizumab. (2) Arm B (Comparator): CCRT, definitive radiotherapy concurrent with two cycles of cisplatin. The primary hypothesis is that the addition of induction chemoimmunotherapy and adjuvant immunotherapy improves event-free survival compared to chemoradiotherapy alone.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
"Not amenable to curative surgery" includes unresectable disease (anatomic impossibility of resection) or inoperable disease (patient medically unable to tolerate or declining surgical resection).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive three cycles of induction chemoimmunotherapy (tislelizumab + paclitaxel-cisplatin) before initiation of CCRT. During CCRT, participants receive two cycles of concurrent cisplatin. After completion of radiotherapy, participants receive additional 13 cycles of adjuvant tislelizumab.
Biological: Tislelizumab · Drug: Paclitaxel · Drug: Cisplatin (75 mg/m2) · Radiation: Intensity-Modulated Radiotherapy · Drug: Cisplatin (80 mg/m2)
Participants receive standard-of-care CCRT, consisting of IMRT with a total dose of 70Gy and two cycles of concurrent cisplatin.
Radiation: Intensity-Modulated Radiotherapy · Drug: Cisplatin (80 mg/m2)
* As induction immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 3 cycles. * As adjuvant immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 13 cycles.
Also known as: Tevimbra
\- As induction chemotherapy, 175 mg/m2 administered IV infusion on Day 2 of each 21-day cycle, for 3 cycles.
Drug page: Cisplatin
\- As induction chemotherapy, 75 mg/m2 administered IV infusion on Day 2-4 of each 21-day cycle, for three cycles.
\- Definitive IMRT: 70Gy given in 35 fractions over 7 weeks
Also known as: IMRT
Drug page: Cisplatin
\- As concurrent chemotherapy, 80 mg/m2 administered IV infusion on Day 1-3 of each 21-day cycle, for two cycles.
Event-free Survival (EFS)
Defined as the time to the earliest occurrence of progressive disease that precluded chemoradiotherapy or prevented completion of chemoradiotherapy, disease recurrence, or death from any cause.
Time frame: 2 year
Overall Survival (OS)
Defined as the time from randomization to death due to any cause.
Time frame: 2 year
Locoregional Recurrence-Free Survival (LRFS)
Defined as the time from randomization to the first documented event of local or regional recurrence.
Time frame: 2 year
Distant Metastasis-free survival (DMFS)
Defined as the time from randomization to the first documented event of distant metastasis.
Time frame: 2 year
Objective Response Rate (ORR)
Defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST). ORR will be evaluated after induction treatment, CCRT, and adjuvant immunotherapy, respectively.
Time frame: Through study completion, an average of 1 year
Incidence of Adverse Events
All adverse events will be documented, including treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs), in the form of all-grade AEs and grade 3-4 AEs. AEs will be evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0.
Time frame: 2 year
Quality of Life (QoL) (EORTC QLQ-H&N35)
Changes in QoL of participants from baseline to up to 6 months after the completion of adjuvant immunotherapy. QoL will be evaluated with the questionnaires of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30).
Time frame: Baseline and up to 6 months
Quality of life (Qol) (FACT-HN)
Changes in QoL of participants from baseline to up to 6 months after the completion of adjuvant immunotherapy. QoL will be evaluated with the questionnaires of the general and head-and-neck-specific (HN) module of the evaluation tool developed by the Functional Assessment of Cancer Therapy (FACT).
Time frame: Baseline and up to 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.
Of 298 non-industry phase 2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 85. This study's planned 39 months is below that.
Counting every sponsor, half of 366 studies reached it within 53 months; a quarter within 35 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Tislelizumab · Paclitaxel · Cisplatin
Squamous Cell Carcinoma of Head and Neck →