Clinical Trial

Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC

Study acronym: RAIN-HNSCC
Not Yet Recruiting Phase 2
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Summary
The purpose of this randomized Phase II study is to evaluate and compare the efficacy and safety of neoadjuvant radio-immunotherapy versus immunotherapy alone for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Participants will be randomly assigned to one of two groups. The experimental group will receive a combination of radiotherapy and Adebrelimab as neoadjuvant treatment, while the control group will receive Adebrelimab monotherapy. Following the neoadjuvant phase, all eligible patients will undergo surgical resection. The primary objective is to determine if the addition of radiotherapy improves the major pathological response (MPR) rate. Secondary objectives include pathological complete response (pCR) rate, objective response rate (ORR), and event-free survival (EFS).
Trial Details
NCT Number NCT07554768
Lead Sponsor Chen Chunyan
Collaborators: Shanghai Shengdi Pharmaceutical Co., Ltd
Conditions Head and Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
Enrollment 36 participants
Start Date 2026-05-01
Primary Completion 2028-05-01 (estimated)
Study Completion 2029-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-28