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

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 per

Trial Details

NCT ID
NCT07445048
Phase
PHASE3
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Bemcentinib
  • Nimotuzumab
  • radiotherapy
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Age ≥ 18 years.
  • Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age \> 70 years;② Renal insufficiency (creatinine clearan…
  • Histologically confirmed locally advanced head and neck squamous cell carcinoma (AJCC 8th edition Stage III-IVB), including oral cavity cancer, HPV…
  • Underwent radical surgery with at least one high-risk feature:

For full eligibility, visit ClinicalTrials.gov.

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