Phase IIIII Study Comparing Serplulimab Plus Bevacizumab and XELOX Chemotherapy to Placebo Plus Bevacizumab and XELOX in First-Line Treatment of Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the clinical effectiveness of Serplulimab HLX10 combined with Bevacizumab and chemotherapy XELOX compared to a placebo combined with Bevacizumab and XELOX chemotherapy in treating patients with metastatic colorectal cancer mCRC who have not previously received systemic treatment for metastatic or recurrent disease. This phase IIIII randomized, double-blind, multicenter study aims to assess how well these treatments work as a first-line therapy in this patient group. The study includes a safety run-in period enrolling 6-12 patients, followed by a phase II study with about 100 patients split evenly between treatment and control groups, and a larger phase III study involving approximately 568 patients across multiple countries. Participants receive either Serplulimab at a fixed 300 mg dose intravenously every three weeks plus Bevacizumab 7.5 mgkg IV every three weeks and XELOX chemotherapy, or placebo plus Bevacizumab and XELOX chemotherapy. The treatment period consists of 3-week cycles lasting up to two years. Participants will undergo a screening period up to 28 days before treatment, followed by treatment cycles and a follow-up phase including safety monitoring and survival checks every 12 weeks. Researchers will evaluate progression-free survival as the primary outcome, along with other measures such as overall survival, response rates, and disease control. Assessments will include tumor measurements, gene testing from tumor tissue, and monitoring of organ function and performance status throughout the study.

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)