drugset / Trial / NCT04547166

A Clinical Study to Evaluate Efficacy and Safety of Serplulimab(HLX10) Combined With Bevacizumab(HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)

NCT04547166

Phase 2/3 Recruiting 568 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)

Timeline

Start
2021-03-10
Primary completion
2025-09-24
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Serplulimab Monoclonal antibody 300 mg Intravenous
Background Bevacizumab Monoclonal antibody 7.5 mg/kg

Indications