drugset / Trial / NCT05024019

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

NCT05024019

Phase 2 Unknown 95 enrolled Eye & ENT Hospital of Fudan University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-08-21
Primary completion
2025-08-21
Completion
2025-08-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 200 mg