NCT05831930

The Effect of Nitozumab in the Treatment of Head and Neck Squamous Cell Carcinoma

Radiotherapy Combined With Nitozumab and Sinilimab in the Treatment of Locally Advanced Unresectable Platinum Intolerant Head and Neck Squamous Cell Carcinoma： an Open-label Single-arm, Phase II Trial

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For patients with locally advanced head and neck tumors who are over 70 years old, have PS\>2, have hearing impairment, renal dysfunction, or have neuropathy greater than grade 1 that is intolerant to cisplatin, radiotherapy alone or combined with EGFR monoclonal antibody radiotherapy should be chosen. The purpose of this study is to demonstrate the superior efficacy of Nitozumab and Sinilimab when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently.

Conditions

• HNSCC

Interventions

Type	Name	Description
DRUG	Nituozumab	Nituozumab injection 200mg, administered once a week on the first day, with a duration of at least 60 minutes for a total of 7 times

Timeline

• Start date: 2023-01-17
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-04-26
• Last updated: 2023-04-26

Locations

1 site across 1 country: China