NCT07812467Not yet recruitingPhase 2
Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy for Oral or Oropharyngeal Squamous Cell Carcinoma
A Phase II Randomized Controlled Clinical Trial of Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy in Patients With Oral/Oropharyngeal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 19 Jul 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07812467
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 220
- From Oct 2026 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe cardiac, hepatic, or renal dysfunction.
- Active autoimmune disease.
- Known allergy or hypersensitivity to rimegepant or any component of the planned neoadjuvant treatment.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- Age 18 to 75 years, regardless of sex.
- Histologically or cytologically confirmed oral or oropharyngeal squamous cell carcinoma, including primary disease or recurrent disease after previous treatment that is considered amenable to repeat curative-intent resection.
- Planned to receive neoadjuvant chemoimmunotherapy followed by surgery after multidisciplinary evaluation.
- At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate major organ function.
- Voluntary participation and provision of written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.