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Recruiting PHASE2 INTERVENTIONAL NCT05777824

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: anti-PD-1 or PD-L1 antibody
Type: COMBINATION_PRODUCT
Description: immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
Name: postoperative radiaotherapy
Type: RADIATION
Description: postoperative radiotherapy (60Gy or 50Gy)

Primary Outcomes

Measure: Disease-free survival
TimeFrame: 2 years
Description: defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment.

Trial Information

NCT ID

NCT05777824

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Last Updated

December 15, 2025