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Local Immunomodulation After Radiofrequency of Unresectable Colorectal Liver Metastases

NCT04062721 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-04-06

No results posted yet for this study

Summary

The main objective of this trial is to determine feasibility and tolerance of the human body to RFA associated with local immunomodulation carried out using a thermoreversible hydrogel combined with 2 immunomodulators, GMCSF and Mifamurtide.

The main endpoint of the study is the feasibility, the frequency and the nature of per and post-operative adverse events of the in situ injection of an immunomodulatory hydrogel after radiofrequency of unresectable colorectal liver metastases.

The secondary objective is one-year progression free survival rate.

Conditions

  • Unresectable Colorectal Liver Metastases

Interventions

DRUG

Chemotherapy

Chemotherapy (at the investigator's choice) for ≥ 2 months before RFA (with controlled disease) and resumed 4-6 weeks after RFA to achieve 6-month total duration.

PROCEDURE

Radiofrequency ablation (RFA)

Complete macroscopic ablation by RFA.

DRUG

In situ immunotherapy

Hydrogel combining TLR or NOD2 agonist and GM-CSF will be injected in 1, 2 or 3 distinct lesions after RFA.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Robert Malafosse, MD · Digestive Surgery Department, Ambroise Pare University Hospital, Boulogne-Billancourt, France

  • Cindy NEUZILLET, MD, PhD · Digestive Surgery Department, Ambroise Pare University Hospital, Boulogne-Billancourt, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT04062721 on ClinicalTrials.gov