drugset / Trial / NCT06491355

First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer

NCT06491355

Phase 2 Unknown 72 enrolled Sir Run Run Shaw Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, multi-center, randomized controlled clinical intervention study, aiming to explore the effectiveness and safety of mfolfox6 and hlx04 regimens combined with slulimumab as first-line treatment for MSS-type initial unresectable metastatic colorectal cancer after induction therapy. This study plans to include a total of 72 patients with untreated MSS-type initial unresectable metastatic colorectal cancer. This study randomly allocated groups through a randomization system, and entered the following treatment groups at a ratio of 1:1: (1) Experimental group: mfolfox6 and hlx04 regimen induction therapy followed by slulimab treatment (36 cases); (2) Control group Group: mfolfox6 and hlx04 regimen treatment (36 cases).

Timeline

Start
2024-07-01
Primary completion
2025-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Serplulimab Monoclonal antibody
Background Bevacizumab Monoclonal antibody
Background Leucovorin Small molecule
Background Oxaliplatin Small molecule
Background fluorouracil Small molecule

Indications