NCT06368141

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Serplulimab	Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.
DRUG	Capecitabine	Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.
DRUG	Oxaliplatin	Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-02-28
• Completion: 2026-04-30
• First posted: 2024-04-16
• Last updated: 2025-09-24

Locations

1 site across 1 country: China