NCT06345287

Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC

Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.

Detailed description

Induction chemotherapy combined with immunotherapy has shown promising efficacy in locally advanced head and neck cancers. However, the appropriate dose and range of the following radical radiotherapy treatment remains unknown. Eligibility patients were assigned to three arms depending on the degree of clinical remission: clinical complete response (radiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance), deep partial response (radiotherapy 66Gy + concurrent chemotherapy + immunotherapy maintenance, non-deep partial response (radiotherapy 70Gy + concurrent chemotherapy + immunotherapy maintenance). Progression-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
RADIATION	radical radiotherapy (60Gy)	concurrent chemoradiotherapy (60Gy) after induction therapy
RADIATION	radical radiotherapy (66Gy)	concurrent chemoradiotherapy (66Gy) after induction therapy
RADIATION	radical radiotherapy (70Gy)	concurrent chemoradiotherapy (70Gy) after induction therapy
COMBINATION_PRODUCT	anti-PD-1 or PD-L1 antibody	immunotherapy maintenance with anti-PD-1 or PDL1antibody every three weeks for 1 year after radiotherapy

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-04-03
• Last updated: 2024-04-03

Locations

1 site across 1 country: China