At a glance
ClinicalIndex Comparison Record- ✓Histopathologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma
- ✓Life expectancy at least 12 weeks
- ✓Treatment-naive for metastatic colorectal adenocarcinoma
- ✓If prior neoadjuvant/adjuvant therapy, time to recurrence/progression must exceed 12 months
- ✕Confirmed MSI-H colorectal cancer
- ✕Oligometastatic liver disease with potential for resection
- ✕CNS or leptomeningeal metastases
- ✕Radiotherapy within 6 months prior to study treatment (with limited exceptions)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04547166Phase 3RecruitingUpdate OverdueUpdated 20mo ago · Completion was 9mo agoA Randomized, Double-blind, Multicenter, PhaseⅡ/Ⅲ Clinical Study of Serplulimab 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)
In Brief
A Phase 3 clinical trial evaluating HLX10 and HLX04、 for Metastatic Colorectal Cancer. Currently recruiting, targeting 568 participants across 5 sites in 2 countries.
Signals
Detailed 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)
Study Details
Timeline
Interventions
a single fixed dose of 300 mg, intravenous infusion (IV), every 3 weeks (Day 1 of each cycle \[D1\]), non-reducible.
7.5mg/kg, IV, every 3 weeks (D1 of each cycle), non-reducible.