Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer

Sponsor
Ruijin Hospital
Study ID
NCT06368141
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Serplulimab — DRUG
    Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.
  • Capecitabine — DRUG
    Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.
  • Oxaliplatin — DRUG
    Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.

Study Details

The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are: * Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer? * Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer? Participants will receive: * a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen. * a sequential CAPEOX plus Serplulimab regimen. * a standard complete mesocolic excision (CME) operation.

Key Dates

Start date
May 1, 2024
Status verified
Sep 2025
Primary completion
Feb 28, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NeoCHIC group

Primary Outcome Measure

pathologic complete response [ Time Frame: 2 weeks after operation ]

Central Contacts

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