This is a randomized, double-blind, phase III clinical trial. The study aims to demonstrate that the treatment regimen of Enlituo® plus FOLFOX is equivalent to that of Erbitux® plus FOLFOX in participants with RAS/BRAF wild-type and MSS/pMMR locally advanced/metastatic colorectal cancer.
Enrolled participants will be stratified according to ECOG performance status (0 vs. 1) and primary tumor location (left-sided or right-sided colon) and randomly assigned in a 1:1 ratio to either the experimental group (Enlituo® + FOLFOX) or the control group (Erbitux® + FOLFOX).
Participants will:
* Receive Enlituo®/Erbitux®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks.
* Receive FOLFOX
* Participants in the Erbitux® plus FOLFOX group who achieve CR, PR, or SD at 16 weeks will cross over to receive Enlituo® plus FOLFOX.
* Be recommended to undergo efficacy assessments every 8 weeks (±7 days).
* Comply with the blood sample collection procedures for pharmacokinetic (PK) and immunogenicity analyses.
* Be required to provide baseline tumor biopsy specimens or 8-10 unstained slides of archived tumor tissue (formalin-fixed, paraffin-embedded) from within the past 3 years.
The Blinded Independent Central Review (BIRC) will assess:
* Objective Response Rate (ORR) within 16 weeks.
* Disease Control Rate (DCR) within 16 weeks.
* Duration of Response (DoR).
* Progression-Free Survival (PFS).
The investigators will assess:
* ORR within 16 weeks.
* DCR within 16 weeks.
* DoR.
* PFS.
* Overall Survival (OS).
* Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as findings from laboratory tests, vital signs, and physical examinations.
* Dose intensity, and incidence of dose interruptions, dose reductions, and treatment discontinuations due to AEs.