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Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC
Sponsor: Chen Chunyan
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).
Official title: A Randomized, Controlled, Phase II Clinical Study of Neoadjuvant Radio-immunotherapy Versus Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-05-01
Completion Date
2029-05-01
Last Updated
2026-04-28
Healthy Volunteers
No
Conditions
Interventions
Adebrelimab
A humanized IgG4 monoclonal antibody against programmed cell death-ligand 1 (PD-L1). Dosage: 1200 mg administered via intravenous (IV) infusion on Day 1 of each 21-day cycle, for a total of 2 cycles in the neoadjuvant setting.
radiotherapy
Neoadjuvant radiotherapy targeting the primary tumor and involved cervical lymph nodes. (SBRT with a total dose of \[24\] Gy in \[3\] fractions).
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China