RecruitingPhase 1NCT06848465

LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis

A Phase Ib Trial on the Safety and Feasibility of Low Dose Radiotherapy (LDRT) Combined With Immunochemotherapy for Colorectal Cancer With Liver-limited Metastasis

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Enrollment

9 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Liver Metastasis LDRT

Summary

In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding low-dose radiation therapy (LDRT) to immunotherapy and chemotherapy improves outcomes for patients with colorectal cancer that has spread to the liver and does not respond well to immunotherapy alone (a subtype called MSS/pMMR). **You may be eligible if...** - You are between 18 and 75 years old - Your colon or rectal cancer has been confirmed by biopsy and is classified as MSS or pMMR - Your rectal cancer is locally advanced (T3-4 or node-positive) based on imaging - You have liver metastases (cancer spread to the liver) confirmed by imaging at the same time as your primary cancer diagnosis - You are suitable for surgery or ablation of your liver metastases **You may NOT be eligible if...** - Your cancer is MSI-high or dMMR (which responds differently to immunotherapy) - Your cancer has spread to organs other than the liver - You have received prior systemic treatment for metastatic disease - You have significant heart disease or other serious medical conditions 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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