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

Metastatic Colorectal Cancer (mCRC) Clinical Trial

Official title:
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 Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Colorectal Neoplasms
Metastatic Colorectal Cancer (mCRC)

Clinical Trial Details

NCT number	NCT03511963
Study type	Interventional
Source	Shanghai Henlius Biotech
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	April 9, 2018
Completion date	April 30, 2024

View Details

See also
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