Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Zaawansowany lub przerzutowy rak jelita grubego potwierdzone badaniami histologicznym lub cytologicznym
- •Co najmniej jedno widoczne na obrazowaniu ognisko nowotworu
- •Brak wcześniejszego leczenia chemioterapią dla zaawansowanego raka jelita grubego
- •Ogólny stan zdrowia oceniony jako 0 lub 1 (pacjent w dobrej kondycji, może wykonywać normalne czynności)
- •Oczekiwana długość życia co najmniej 12 tygodni
- •Prawidłowe parametry krwi: liczba neutrofili, płytki krwi, hemoglobina
- •Prawidłowa funkcja wątroby i nerek
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 5, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Sun Yat-Sen University Cancer Center
Guangzhou, China
Trial contact
Jiang Guo
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/6/2026.
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