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

NCT06368141 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-09-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Ren Zhao, PhD · Ruijin Hosipital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-02-28
Completion
2026-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06368141 on ClinicalTrials.gov