NCT04882462

Sintilimab and Nimotuzumab Combined With Chemotherapy for the Treatment of R/M HNSCC.

A Multicenter, Single-arm Study of Sintilimab and Nimotuzumab Combined With Chemotherapy for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of Sintilimab and Nimotuzumab in combination with chemotherapy in patients with newly diagnosed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The main endpoint is progression free survival (PFS); the secondary endpoint are objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.

Conditions

• Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nimotuzumab	Nimotuzumab, 400mg, intravenously every 3 weeks, for at least 18 weeks
DRUG	Sintilimab	Sintilimab, 200mg, intravenously every 3 weeks, for at least 18 weeks;
DRUG	Chemotherapy drug	Chemotherapy drugs were selected by the investigator, every 3 weeks, for 18 weeks

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-11-30
• Completion: 2022-12-31
• First posted: 2021-05-12
• Last updated: 2021-05-12