RecruitingPhase 2NCT06154538

Immune Checkpoint Inhibitors + Chemotherapy Versus Chemotherapy in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer

Comparison of Immune Checkpint Inhibitors Combined With Chemotherapy Versus Chemotherapy Alone in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer: a Randomized, Open-label, Single-center Phase II Clinical Study


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

170 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the efficacy and safety of the combination of immune checkpoint inhibitors (ICIs) and FOLFOX regimen compared to FOLFOX regimen alone in the neoadjuvant chemotherapy of locally advanced colorectal cancer. The main question aims to answer are: Question 1: Compare the pathological complete response rate between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Question 2: Compare the survival outcomes and safety between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Two groups of participants will receive different new adjuvant chemotherapy regimens, and their efficacy will be compared.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding immune checkpoint inhibitors (a type of immunotherapy) to standard chemotherapy before surgery can improve outcomes in people with locally advanced colorectal cancer (stage II or III, cancer that has not spread to distant organs). It compares chemotherapy alone versus chemotherapy plus immunotherapy as a pre-surgical treatment (called neoadjuvant therapy). **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with stage II or III colorectal adenocarcinoma (confirmed by biopsy) - Your cancer is locally advanced but has not spread to distant organs (no metastases) - You have not had prior chemotherapy or radiation for colorectal cancer - You are in good health (ECOG 0–1) with adequate organ function - Tumor tissue is available for genetic testing (mismatch repair/microsatellite instability) **You may NOT be eligible if...** - Your cancer is not the adenocarcinoma type (e.g., squamous, melanoma, GIST) - Your cancer has spread to distant organs (metastatic disease) - You have had another cancer in the past 5 years (with some exceptions for skin or in situ cancers) - You have significant autoimmune disease or uncontrolled bleeding 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

DRUGImmune checkpoint inhibitor

PD-1 antibody

DRUGFOLFOX regimen

FOLFOX chemotherapy


Locations(3)

Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

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NCT06154538


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