RecruitingPhase 2NCT06368141

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

Sponsor

Ruijin Hospital

Enrollment

56 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Colon Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving chemotherapy before surgery, followed by an immune checkpoint inhibitor (immunotherapy), can improve outcomes for people with locally advanced colon cancer that has certain genetic features (MSS/RAS mutation). **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of locally advanced colon cancer (adenocarcinoma) - Your tumor has been tested and is MSS (not microsatellite unstable) with a RAS mutation - Your cancer is considered locally advanced but potentially resectable **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have prior colon cancer treatment or surgery - You have serious heart, liver, or immune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.

DRUGCapecitabine

Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.

DRUGOxaliplatin

Participants will receive a pre-operative CAPEOX and a sequential CAPEOX plus Serplulimab regimen.

Locations(1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

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NCT06368141

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