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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

Completed Phase 3 Last updated 31 December 2024
What this trial tests

Phase 3 trial testing HLX04 100 mg in 4 ml Injection in Metastatic Colorectal Cancer (mCRC) in 677 participants. Completed in 20 April 2023.

Timeline
9 April 2018
Primary endpoint
15 April 2020
20 April 2023

Quick facts

Lead sponsorShanghai Henlius Biotech
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment677
Start date9 April 2018
Primary completion15 April 2020
Estimated completion20 April 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Henlius Biotech — full company profile →

Who can join

Adults 18 to 75, any sex, with Metastatic Colorectal Cancer (mCRC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy, Safety, and Immunogenicity of HLX04 Versus Reference Bevacizumab in Combination with XELOX or mFOLFOX6 as First-Line Treatment for Metastatic Colorectal Cancer: Results of a Randomized, Double-Blind Phase III Study.
    Qin S, Li J, Bai Y, Shu Y, et al · · 2021 · cited 28× · PMID 34014555 · DOI 10.1007/s40259-021-00484-9
  2. A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteers.
    Zhu X, Qian H, Sun J, Wu M, et al · · 2021 · cited 10× · PMID 34086067 · DOI 10.1007/s00280-021-04297-z
  3. Efficacy and Safety of Bevacizumab Biosimilars Compared With Reference Biologics in Advanced Non-small Cell Lung Cancer or Metastatic Colorectal Cancer Patients: A Network Meta-Analysis.
    Xu X, Zhang S, Xu T, Zhan M, et al · · 2022 · cited 8× · PMID 35865968 · DOI 10.3389/fphar.2022.880090
  4. Tumor-infiltrating regulatory T cell: A promising therapeutic target in tumor microenvironment.
    Huang T, Li F, Wang Y, Gu J, et al · · 2024 · cited 2× · PMID 39679474 · DOI 10.1097/cm9.0000000000003450
  5. Biosimilar monoclonal antibodies for cancer treatment in adults.
    Galvao TF, Livinalli A, Lopes LC, Zimmermann IR, et al · · 2024 · cited 2× · PMID 39607013 · DOI 10.1002/14651858.cd013539.pub2
  6. Hepatic Arterial Infusion Chemotherapy with Serplulimab and the Bevacizumab Biosimilar HLX04 for Advanced Hepatocellular Carcinoma: A Prospective, Observational Phase II Clinical Trial.
    Li H, Si T, Li R, Xie X, et al · · 2025 · cited 1× · PMID 41097761 · DOI 10.3390/cancers17193235

Verify or expand the search:

Other recruiting trials for Metastatic Colorectal Cancer (mCRC)

Currently open trials in the same condition.

Other Shanghai Henlius Biotech trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03511963.

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