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

Recruiting Phase 3 Interventional Study
Head & Neck Squamous Cell Carcinoma Head & Neck Cancer Postoperative Adjuvant Treatment
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
370 (estimated)
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age \> 70 years;② Renal insufficiency (creatinine clearance \< 50 mL/min; criterion ⑩ below does not apply if this criterion is met);③ Severe tinnitus or hearing impai…
Contacts

Guopei Zhu

23211699-5665

antica@gmail.com

CONTACT

Shengjin Dou

17521066068

doushengjin@126.com

CONTACT