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

NCT06491355 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-07-09

No results posted yet for this study

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).

Conditions

  • Efficacy, Self
  • Safety Issues
  • Colo-rectal Cancer

Interventions

DRUG

mfolfox6 and hlx04 regimen and Serplulimab

mfolfox6 and hlx04 regimen induction therapy followed by combined treatment with slulimumab in the experimental arm. In the active comparator. only with mfolfox6 and hlx04 regimen treatment.

DRUG

mfolfox6 and hlx04 regimen

In the active comparator. only with mfolfox6 and hlx04 regimen treatment.

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06491355 on ClinicalTrials.gov