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

Sponsor
Yue He, MD
Study ID
NCT07432087
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab and Cetuximab — DRUG
    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.
  • Camrelizumab and Chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2033

Study Design

Enrollment
246 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab and Cetuximab
    Camrelizumab (Day 1) and Cetuximab Beta (Day 1, Day 8, Day 15), 2 cycles
  • Active Comparator: Camrelizumab and Chemotherapy
    Camrelizumab (Day 1), Paclitaxel Albumin - bound (Day 1, Day 8) and Carboplatin (Day 1), 2 cycles

Primary Outcome Measure

2-year Overall Survival (OS) Rate [ Time Frame: 2 years from the date of randomization ]

Central Contacts

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