Colorectal Cancer Immunomonitoring Combined With Radiofrequency ablatIon — ColIBRI  

Colorectal Cancer Clinical Trial

Official title: Colorectal Cancer Immunomodulation Combined to Radiofrequency ablatIon

Status Not yet recruiting

Clinical Trial Summary

The primary objective of the study aims to compare soluble CD154 (CD40L) levels before and after radiofrequency ablation (RFA) in patients with colorectal cancer (CRC) liver metastases.

The secondary objectives aims:

• to compare soluble CD154 (sCD40-L) levels before and after treatment by RFA or surgery alone in patients with CRC liver metastases;

• to study the feasibility and reliability of soluble CD154 (sCD40-L) levels to detect and quantify the induction of immun response in CRC liver metastases patients after RFA;

• to study the impact of surgery on plasma soluble CD154 levels;

• to study association between CD154 expression level before and after RFA in CRC liver metastases patients and relapses rate at 1 year.

Clinical Trial Description

Radiofrequency ablation (RFA) of colorectal liver metastases activates a specific T-cell response that is ineffective in avoiding recurrence. Local immunomodulation garnered interests as a way to improve the immune response. It was interesting in improving the RFA immune response priming to propose a curative treatment of colorectal cancer (CRC) based on antitumor immunity. Early study of the investigators demonstrated that the RFA did not increase the tumor infiltrating lymphocytes in secondary distant tumors of patients and in mice model and could not avoid relapse. The lack of an effective distant immune response in patients treated with RFA confirmed the relevance of the combination strategy.

Another study on the predictive value of cytokines/chemokines in rectal cancer (RC) patients receiving chemoradiation therapy (CRT) demonstrate that, the pre-CRT levels of soluble CD40-ligand (sCD40L) and the post-CRT levels of chemokine ligand-5 (CCL-5) were significantly associated with the depth of tumor invasion and with venous invasion. A significant correlation between pre-CRT platelet counts and sCD40L was observed in patients with a favorable response.

Today there is no validated biomarker for the indication of immunotherapy after local treatment on metastases of colorectal cancer.

This is a prospective, monocentric study which will be realized with the routine care and usual management. There will be any added intervention for enrolled patients during the study. All eligible patients will be enrolled and followed in the Department of digestive surgery of Ambroise Paré Hospital - APHP.

The duration of enrollment will last 6 months. The duration of follow-up for each patient will be up to 12 month.

Data collection: the medical data will be collected and recorded by Doctor Malafosse in a Excel file. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Radiofrequency ablatIon

• NCT number: NCT04420013
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Robert MALAFOSSE, MD
• Phone: +33 (0)149095586
• Email: robert.malafosse@aphp.fr
• Status: Not yet recruiting
• Start date: September 2020
• Completion date: March 2022