NCT05024019

Nimotuzumab Combined With Radiotherapy in High-risk Patients With HNSCC Not Suitable for Cisplatin After Surgery

A Multicenter Clinical Study of Nimotuzumab Combined With Concurrent Radiotherapy Versus Radiotherapy Alone in High-risk Patients With Head and Neck Squamous Cell Carcinoma Not Suitable for Cisplatin After Surgery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open label, multicenter, randomized controlled clinical trial. The main purpose of the study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent radiotherapy versus radiotherapy alone in high-risk patients with HNSCC not suitable for cisplatin after surgery. The subjects were randomly divided into study group (nimotuzumab combined with concurrent radiotherapy) and control group (radiotherapy alone) by 1∶1 stratified random method.

Detailed description

This study is a prospective, open label, multicenter, randomized controlled clinical trial. The main purpose of the study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent radiotherapy versus radiotherapy alone in high-risk patients with HNSCC not suitable for cisplatin after surgery. The subjects were randomly divided into study group and control group by 1∶1 stratified random method. The study group received nimotuzumab (200mg, weekly, for 6 weeks) combined with concurrent radiotherapy, while the control group received radiotherapy alone. The main endpoint is 2 year disease free survival (DFS) rate.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nimotuzumab	The study group received nimotuzumab (200mg, weekly, for 6 weeks) in combination with radiotherapy.

Timeline

• Start date: 2021-08-21
• Primary completion: 2025-08-21
• Completion: 2025-08-21
• First posted: 2021-08-27
• Last updated: 2021-08-27

Locations

6 sites across 1 country: China