NCT05476965

Selected De-escalation Radiotherapy for Postoperative Head and Neck Squamous Cell Carcinoma

A Phase II Trial of Cisplatinum, Paclitaxel, and Sintilimab Induction Therapy Followed by De-escalation Radiotherapy for Patients With Postoperative Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hubei Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is looking to see if sintilimab, an anti-PD-1 McAb given with cisplatinum and paclitaxel (2 chemotherapy agents) during induction therapy in advanced head and neck squamous cell carcinoma can significantly shrink the subject's cancer, then de-escalation radiotherapy can be used.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Radiotherapy
• Immunotherapy
• Surgery

Interventions

Type	Name	Description
COMBINATION_PRODUCT	induction therapy; surgery; radiotherapy	Radiotherapy: de-escalation radiotherapy or standard radiotherapy

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-01
• Completion: 2024-06-01
• First posted: 2022-07-27
• Last updated: 2022-07-27

Locations

1 site across 1 country: China