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NOT YET RECRUITING
NCT06722495
NA

Efficacy and Safety of a Third-Course of Neoadjuvant Immunochemotherapy Combined With SBRT in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients With Stable Disease After Two Treatment Courses: A Single-Arm Exploratory Study

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

Neoadjuvant immunotherapy before surgery has shown good efficacy and safety in locally advanced HNSCC, particularly with the use of PD-1 inhibitors combined with chemotherapy, where some patients have achieved a high rate of pathological complete response. However, approximately 40% of patients respond poorly to neoadjuvant immunochemotherapy, with prolonged treatment courses failing to significantly improve outcomes, and some patients may even experience disease progression. For these patients, timely surgery or definitive radiotherapy combined with other well-tolerated therapeutic approaches is needed to improve pathological response rates, enhance long-term survival, and preserve organ function.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-12-24

Completion Date

2026-12-26

Last Updated

2024-12-09

Healthy Volunteers

No

Interventions

RADIATION

SBRT

Patient will receive SBRT (8Gy\*3F) in combination with the original regimen of neoadjuvant immunochemotherapy in course 3. Gross tumor target volume (GTV) based on the primary foci clearly identified by clinical and imaging examinations. The GTV was discharged 3 mm to generate a Planning target volume (PTV). the target area (PTV) was dosed accordingly to the PTV.

Locations (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China