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Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 5, 2026 to Mar 4, 2026
    • Study title revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy. The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.
Trial Details
NCT Number NCT07445048
Lead Sponsor Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions
(from sponsor)		 Head & Neck Squamous Cell Carcinoma, Head & Neck Cancer, Postoperative Adjuvant Treatment
Related terms Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 370 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov