Camrelizumab Combined With EGFR Monoclonal Antibody or Chemotherapy for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT07432087 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246
Last updated 2026-02-25
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
Interventions
- 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.
Sponsors & Collaborators
-
Yue He, MD
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2030-12-31
- Completion
- 2033-12-31
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