NCT07432087

Camrelizumab Combined With EGFR Monoclonal Antibody or Chemotherapy for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Randomized Controlled Trial of Camrelizumab Combined With EGFR Monoclonal Antibody or Chemotherapy for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Yue He, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, controlled, multicenter, non-inferiority clinical study designed to evaluate the efficacy and safety of camrelizumab combined with EGFR monoclonal antibody or chemotherapy as perioperative treatment of locally advanced head and neck squamous cell carcinoma.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab and Cetuximab	Camrelizumab 200 mg (Day 1) intravenous infusion (IV), Cetuximab Beta 400 mg/m² (Day 1) IV, followed by 250 mg/m² IV weekly, with a 21-day cycle for 2 cycles; followed by surgical treatment; with or without postoperative radiotherapy/chemoradiotherapy based on risk factors; then Camrelizumab 200 mg (Day 1) IV, with a 21-day cycle for up to 15 cycles.
DRUG	Camrelizumab and Chemotherapy	Camrelizumab 200 mg (Day 1) intravenous infusion (IV) and Paclitaxel Albumin - bound 125 mg/m² (Day 1, Day 8) IV and Carboplatin AUC 4 (Day 1) IV, with a 21-day cycle for 2 cycles; followed by surgical treatment; with or without postoperative radiotherapy/chemoradiotherapy based on risk factors; then Camrelizumab 200 mg (Day 1) IV, with a 21-day cycle for up to 15 cycles.

Timeline

• Start date: 2026-02-01
• Primary completion: 2030-12-31
• Completion: 2033-12-31
• First posted: 2026-02-25
• Last updated: 2026-02-25