Clinical Trial

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)

Recruiting Phase 2/3
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Record status
This record was last updated October 17, 2024 (before its estimated September 24, 2025 completion). Its status may not reflect the trial's current state.
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)
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-09-07; most recent amendment 2024-10-15.
Status change: Active, Not Recruiting → Recruiting 2024-05-31
Status change: Recruiting → Active, Not Recruiting 2022-04-27
Status change: Not Yet Recruiting → Recruiting 2021-11-08
Trial Details
NCT Number NCT04547166
Lead Sponsor Shanghai Henlius Biotech
Conditions Metastatic Colorectal Cancer
Enrollment 568 participants
Start Date 2021-03-10
Primary Completion 2025-09-24 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-17