NCT05777824

Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy

Pathological Response Adapted Decision-making of Postoperative Management for HNSCC Receiving Induction Immunotherapy and Chemotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (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

To develop postoperative stratification treatment for patients who have received induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk stratification is based on clinical characteristics and pathological responses. In order to achieve no inferior survival rate and a lower treatment-related toxicity rate than the standard treatment.

Detailed description

Induction chemotherapy combined with immunotherapy has shown promising efficacy in the treatment of patients with locally advanced head and neck cancers. However, how to choose a proper postoperative treatment remains unknown. Eligibility patients were assigned to two arms, each divided into three groups: observation, immunotherapy maintenance, and radiotherapy (50 Gy dose) plus immunotherapy maintenance group for low-risk arm; radiotherapy (50 Gy or 60Gy dose) plus immunotherapy maintenance groups, concurrent chemotherapy plus immunotherapy maintenance group for a high-risk arm. Disease-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
COMBINATION_PRODUCT	anti-PD-1 or PD-L1 antibody	immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
RADIATION	postoperative radiaotherapy	postoperative radiotherapy (60Gy or 50Gy)

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-12-30
• Completion: 2027-12-30
• First posted: 2023-03-21
• Last updated: 2023-10-11

Locations

1 site across 1 country: China