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

Sponsor
Sir Run Run Shaw Hospital
Study ID
NCT06491355
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • mfolfox6 and hlx04 regimen and Serplulimab — DRUG
    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.
  • mfolfox6 and hlx04 regimen — DRUG
    In the active comparator. only with mfolfox6 and hlx04 regimen treatment.

Study Details

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).

Key Dates

Start date
Jul 1, 2024
Status verified
Jun 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: mfolfox6 and hlx04 regimen induction therapy followed by combined treatment with slulimumab
    Induction therapy: mFOLFOX6 regimen + bevacizumab. lasting 2 cycles. Combination therapy: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody. Every 2 weeks is a cycle.
  • Active Comparator: mfolfox6 and hlx04 regimen treatment
    mFOLFOX6+ HLX04 (bevacizumab). The mFOLFOX6 regimen is: oxaliplatin, calcium leucovorin, 5-fluorouracil, bevacizumab, One cycle is every 2 weeks, lasting 2 cycles. During treatment, the drug was administered continuously, and tumor response was assessed by imaging every 8 weeks.

Primary Outcome Measure

Progression free survival（PFS） [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. ]

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