NCT07400094

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Investigator-initiated, single-arm, phase II study conducted at P.A. Hertsen Moscow Oncology Research Institute. Protocol approved by Local Ethics Committee (#1187/132).

Conditions

• Squamous Cell Carcinoma of Head and Neck
• Laryngeal Neoplasms
• Oral Cavity Neoplasm

Interventions

Type	Name	Description
DRUG	Camrelizumab	200 mg IV on Day 1, every 21 days for 3 cycles
DRUG	Paclitaxel	175 mg/m² IV on Day 1, every 21 days for 3 cycles
DRUG	carboplatin	AUC 6 IV on Day 1, every 21 days for 3 cycles
PROCEDURE	Radical Surgery	Standard radical resection 4-6 weeks after neoadjuvant therapy

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: Russia