Clinical Trial

Neoadjuvant Toripalimab + Chemotherapy ± Cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma (Neo-ICT)

Not Yet Recruiting Phase 3
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Summary
This study is a randomized, active-controlled, open-label clinical trial for participants with newly diagnosed Stage III-IVb, resectable, locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). The study consists of two experimental arms and one control arm. Participants in Experimental Arm A will receive two cycles of Toripalimab, albumin-bound paclitaxel, carboplatin, and cetuximab prior to surgery. Participants in Experimental Arm B will receive two cycles of Toripalimab, albumin-bound paclitaxel, and carboplatin before surgical intervention. Following the surgical procedure, individuals in both Experimental Arm A and B will continue to receive 15 cycles of Toripalimab. The Control Arm will undergo the current standard treatment without preoperative drug intervention. Postoperatively, participants will be administered postoperative radiotherapy or chemoradiotherapy based on their recurrence risk. The primary study hypotheses are that the treatments in the Experimental Arms will improve the 2-year event-free survival (EFS) rates compared to the standard control treatment.
Trial Details
NCT Number NCT06647563
Lead Sponsor Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions Squamous Cell Carcinoma of Head and Neck
Enrollment 355 participants
Start Date 2024-11-01
Primary Completion 2029-09-30 (estimated)
Study Completion 2030-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-18