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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)

Metastatic Colorectal Cancer Clinical Trial

Official title:
A Randomized, Double-blind, Multicenter, PhaseⅡ/Ⅲ Clinical Study of Serplulimab (HLX10) in Combination With Bevacizumab (HLX04) and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab (HLX04) and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)

Clinical Trial 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 (HLX04) and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab (HLX04) and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)

Clinical Trial Description

Patients with confirmed unresectable metastatic/recurrent colorectal adenocarcinoma who have not received systemic anti-neoplastic therapy for metastatic/recurrent lesions will be included in this study.Approximately 6-12 patients will be enrolled in the Part I (Safety Run-in Period).Approximately 100 patients will be enrolled in the Part II (Phase II study, 50 in the test group and 50 in the control group).Approximately 654 patients will be enrolled in the Part III (Phase III study, 327 in the test group and 327 in the control group). Part II (Phase II study): Approximately 40 study sites in China will participate. Part III (Phase III study): A total of approximately 75 study sites in 7 countries(including China, the United States, Brazil, Indonesia, Russia, Poland, Spain, etc.) will participate. The study consists of a screening period (up to 28 days), a treatment period (3-week cycle, up to 2 years), and a follow-up period (including a safety follow-up period, and a survival follow-up every 12 weeks). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04547166
Study type Interventional
Source Shanghai Henlius Biotech
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date March 10, 2021
Completion date June 30, 2025
View Details
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