A Phase 2 interventional study of Rimegepant and Tislelizumab in Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (OPSCC), sponsored by Shanghai Zhongshan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
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Among 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China — 171 open to participants now, 205 under way, 25 of them phase 3. Squamous Cell Carcinoma of Head and Neck · China.
Among the 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China, this one is the 53rd largest by planned enrollment of the 265 interventional ones that give a count, is one of 54 that started in 2026, is one of 139 in phase 2, reaches primary completion later than 172 of the 204 other live ones, and was the 278th 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 →171 of the 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China are open now. Recruiting first, the newest first:
Taizhou Mabtech Pharmaceutical Co.,Ltd · Sites in China
Ages 18+
Ji Dongmei · Sites in China
Ages 18–70
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18–75
West China Hospital · Sites in China
Ages 18–75
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
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.
290 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 66 · Phase 2 172 · Phase 3 37 · Phase 4 2
First in 2005; this study’s year is marked. 54 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 220 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 68 across the 265 interventional studies, 136 across the 25 observational. Of the 45 that completed or were terminated, 11 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
89 of 290 have an industry lead sponsor. The 10 most frequent:
Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
Shanghai Zhongshan Hospital has 4 studies filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
58 of the studies in Squamous Cell Carcinoma of Head and Neck with a site in China that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06601335Phase 3AkesoA Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) | 2027-01 |
| NCT06102395Phase 3Beijing Tongren HospitalEvaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC | 2027-04-30 |
| NCT06772428Phase 3Changchun GeneScience Pharmaceutical Co., Ltd.Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery. | 2027-06-30 |
| NCT06668961Sichuan Baili Pharmaceutical Co., Ltd.A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma | 2026-11 |
| NCT06107686MediLink Therapeutics (Suzhou) Co., Ltd.A Study of YL202 in Selected Patients With Advanced Solid Tumors | 2026-11 |
Add all 58 to your calendar (.ics) → With an account.
Among the 290 studies in Squamous Cell Carcinoma of Head and Neck with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will evaluate whether adding rimegepant to standard neoadjuvant chemoimmunotherapy can improve treatment response in patients with primary or recurrent oral or oropharyngeal squamous cell carcinoma who are planned to undergo surgery.
Rimegepant blocks the receptor for calcitonin gene-related peptide, also known as CGRP. CGRP signaling may affect the tumor immune environment and the response of tumors to anticancer treatment.
The study includes an initial safety run-in stage involving 20 participants, followed by a randomized controlled stage involving 200 participants. During the randomized stage, participants will be assigned in a 1:1 ratio to receive standard neoadjuvant chemoimmunotherapy either with or without rimegepant. All participants will receive two cycles of neoadjuvant treatment followed by definitive or intended curative surgery.
The main outcome is the major pathological response rate, defined as 10% or less residual viable tumor in the surgical specimen. Other outcomes include pathological complete response, objective response, event-free survival, overall survival, changes in pain and quality of life, and treatment safety.
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.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Twenty participants will receive rimegepant plus standard neoadjuvant chemoimmunotherapy for two 3-week cycles, followed by definitive or intended curative surgery. Safety and tolerability will be evaluated before initiation of the randomized stage.
Drug: Rimegepant · Drug: Tislelizumab · Drug: Nab-paclitaxel · Drug: Cisplatin
Participants randomized to this arm will receive rimegepant plus standard neoadjuvant chemoimmunotherapy for two 3-week cycles, followed by definitive or intended curative surgery.
Drug: Rimegepant · Drug: Tislelizumab · Drug: Nab-paclitaxel · Drug: Cisplatin
Participants randomized to this arm will receive standard neoadjuvant chemoimmunotherapy alone for two 3-week cycles, followed by definitive or intended curative surgery.
Drug: Tislelizumab · Drug: Nab-paclitaxel · Drug: Cisplatin
Rimegepant 75 mg will be administered orally every other day from the initiation until the completion of neoadjuvant chemoimmunotherapy.
Tislelizumab 200 mg will be administered by intravenous infusion on Day 1 of each 3-week treatment cycle for two cycles.
Nab-paclitaxel 260 mg/m² will be administered by intravenous infusion on Day 2 of each 3-week treatment cycle for two cycles.
A total dose of cisplatin 75 mg/m² will be administered intravenously over Days 2 and 3 of each 3-week treatment cycle for two cycles.
Major Pathological Response Rate
Percentage of participants with 10% or less residual viable tumor cells in the resected primary or recurrent tumor specimen after neoadjuvant treatment. For the randomized efficacy analysis, participants who do not undergo surgery or whose surgical specimens are not evaluable for pathological response will be considered not to have achieved major pathological response. Results will also be reported separately for participants with primary and recurrent disease.
Time frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment
Pathological Complete Response Rate
Percentage of participants with no residual viable tumor cells in the resected primary or recurrent tumor specimen after neoadjuvant treatment, using the same pathological assessment scope as that used for major pathological response. Participants who do not undergo surgery or whose surgical specimens are not evaluable for pathological response will be considered not to have achieved pathological complete response in the randomized efficacy analysis.
Time frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment
Objective Response Rate
Percentage of participants with a complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1.
Time frame: From baseline to preoperative radiographic assessment after completion of two 3-week cycles of neoadjuvant treatment
Event-Free Survival
Event-free survival is defined as the time from randomization to the first occurrence of any of the following: disease progression during neoadjuvant treatment that precludes the planned definitive or intended curative surgery; locoregional recurrence or progression after surgery; distant metastasis or distant disease progression; or death from any cause. Participants without an event will be censored at the date of the last assessment confirming that they remained event-free.
Time frame: From randomization to the first event or censoring, assessed up to 5 years
Overall Survival
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Time frame: From randomization until death or censoring, assessed up to 5 years
Change From Baseline in Pain Score
Change from baseline in pain severity as assessed using the McGill Pain Questionnaire. Changes in pain scores will be compared between treatment groups at protocol-specified assessment time points.
Time frame: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment
Change From Baseline in Quality of Life
Change from baseline in quality-of-life scores assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30.
Time frame: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment
Incidence of Treatment-Emergent Adverse Events
Incidence, type, and severity of treatment-emergent adverse events and serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Time frame: From signing informed consent through 90 days after the last dose of study treatment
Change From Baseline in Peripheral Blood Immune Cell Subset Proportions Assessed by Multiparameter Flow Cytometry
Multiparameter flow cytometry will be used to quantify major immune cell subsets in peripheral blood mononuclear cells, including CD4+ T cells, CD8+ T cells, B cells, natural killer cells, and monocytes. Each immune cell subset will be reported as a percentage of total viable peripheral blood mononuclear cells. Changes from baseline will be reported in percentage points at each post-baseline assessment.
Time frame: At baseline; at the end of Cycle 1 (Day 21); at the end of Cycle 2 (Day 42); and on the day of definitive surgery before anesthesia
Change From Baseline in Tumor-Infiltrating Immune Cell Subset Proportions Assessed by Single-Cell RNA Sequencing
Single-cell RNA sequencing will be used to quantify tumor-infiltrating immune cell subsets in paired pretreatment biopsy and definitive surgical specimens, including T cells, B cells, natural killer cells, macrophages, and other myeloid cells. Each immune cell subset will be reported as a percentage of all viable cells captured in the corresponding specimen. Changes from baseline will be reported in percentage points.
Time frame: At baseline, using the pretreatment biopsy obtained before Cycle 1, and at definitive surgery after completion of two 21-day cycles of neoadjuvant treatment
CGRP Pathway Biomarkers
Changes in the expression of biomarkers related to the calcitonin gene-related peptide signaling pathway in tumor tissue and/or peripheral blood.
Time frame: At baseline, using peripheral blood and the pretreatment tumor biopsy obtained before Cycle 1, and at definitive surgery after completion of two 21-day cycles of neoadjuvant treatment
Plan to share: No — Individual participant data are not currently planned to be shared. The study involves sensitive clinical, pathological, and human genetic resource data. Any future sharing of de-identified participant-level data would require additional institutional ethics review, compliance with applicable Chinese regulations on human genetic resources and data security, and appropriate data use agreements. The registry record will be updated if the sharing plan changes.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 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 24 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 Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rimegepant
Squamous Cell Carcinoma of Head and Neck →