NCT03511963

A Clinical Study to Compare the Efficacy, Safety and Immunogenicity of HLX04 and Bevacizumab Combined XELOX or mFOLFOX6 in the First-line Treatment of mCRC

A Randomized, Double-blind, Parallel Control, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of HLX04 and Bevacizumab Combined With Oxaliplatin and Fluoropyrimidine-based Chemotherapy (XELOX or mFOLFOX6) in the First-line Treatment of Metastatic Colorectal Cancer (mCRC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 677 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in patients with the recurrent lesion(s) post-surgery or the untreated mCRC. After stratification with respect to ECOG PS score, chemo regimen, primary tumor location and KRAS and BRAF genotype (complete wild-type/primal type), eligible patients are randomized into two arms at 1:1 ratio to receive HLX04 (Arm A) or Bevacizumab (Arm B) in combination with one of the protocol-defined chemotherapies, modified FOLFOX6 (mFOLFOX6) or XELOX for mCRC until disease progression (PD) or unacceptable toxicity or achieving an operable contingency, whichever occurs first.

Conditions

• Metastatic Colorectal Cancer (mCRC)

Interventions

Type	Name	Description
DRUG	HLX04 100 mg in 4 ml Injection	7.5 mg/kg iv (XELOX+HLX04) 5 mg/kg iv (mFOLFOX6 + HLX04)
DRUG	Avastin 100 mg in 4 ml Injection	7.5 mg/kg iv (XELOX+HLX04) 5 mg/kg iv (mFOLFOX6 + HLX04)

Timeline

• Start date: 2018-04-09
• Primary completion: 2020-04-15
• Completion: 2023-04-20
• First posted: 2018-04-30
• Last updated: 2024-12-31

Locations

1 site across 1 country: China