drugset / Trial / NCT06333821

A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma

NCT06333821

Phase 3 Not yet recruiting 460 enrolled Biotech Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma. The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival.

Timeline

Start
2024-04-01
Primary completion
2030-04-01
Completion
2030-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 400 mg Intravenous
Background Cisplatin Other / unclassified 40 mg/m2 Intravenous

Indications