NCT07400094Not yet recruitingPhase 2
Neoadjuvant Chemoimmunotherapy (Camrelizumab + Paclitaxel + Carboplatin) for Resectable HNSCC
Prospective Non-Randomized Phase II Study of Neoadjuvant Camrelizumab Combined With Paclitaxel and Carboplatin in Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity and Larynx (Stage III-IVA)
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
This phase II study evaluates the efficacy and safety of neoadjuvant chemoimmunotherapy consisting of camrelizumab (PD-1 inhibitor), paclitaxel, and carboplatin in patients with resectable locally advanced (Stage III-IVA) squamous cell carcinoma of the oral cavity and/or larynx. Fifty patients will receive 3 cycles of therapy (camrelizumab 200 mg IV, paclitaxel 175 mg/m2 IV, carboplatin AUC6 IV, Day 1 every 21 days) followed by radical surgery 4-6 weeks later. Patients are then stratified to risk-adapted adjuvant therapy based on pathological findings (radiation or chemoradiation with cisplatin if adverse features present). The primary endpoint is the pathological complete response (pCR) rate and major pathological response (MPR, \<10% viable tumor cells) rate at surgery. Secondary endpoints include objective response rate (ORR) by imaging (MRI/PET-CT), correlation of PET-CT metabolic response with pathological response, proportion requiring adjuvant chemoradiation, and 3-year event-free survival compared to historical controls. Study period: 2026-2029.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 29 Jan 2026
- Start date
- Feb 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- Diseases
- Head and neck cancer
- NCT number
- NCT07400094
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From Feb 2026 to the primary completion date, Feb 2029
- 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
- Patient refusal to undergo planned treatment
- Protocol violations not related to medical indications
Who the study is looking for
- Histologically confirmed squamous cell carcinoma of the oral cavity and/or larynx, Stage III-IVA (cT1-2N1-2M0, cT3-4aN0-2M0)
- Resectable disease planned for surgical treatment
- Age 18-75 years
- No prior antitumor therapy for the current diagnosis
- Tumor sample available for PD-L1 expression assessment
- No other malignancies in anamnesis (except basal cell carcinoma of skin and carcinoma in situ of cervix)
- Absence of comorbidities preventing systemic chemotherapy and immunotherapy
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 |
|---|---|---|---|
| P.A. Hertsen Moscow Oncology Research Institute Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.