Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin

NCT03960021 | Terminated Results DMC

• 2 other identifiers: IB 2018-032018-A01996-49
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Local percutaneous thermal ablation is frequently proposed in the management of metastatic diseases. Radiofrequency ablation (RFA) has demonstrated good results when the metastatic disease is limited and slowly evolving. The destruction of solid metastasis by RF leads to inflammatory and immunological mechanisms that remain poorly understood. These pathological events may influence the overall and anti-tumor host immune responses. The purpose of the study is to identify and quantify some immune mechanisms triggered by RFA of pulmonary metastases from colorectal cancer origin.

Conditions

Immune Evasion, Tumor; Neoplastic Cells, Circulating; Circulating Tumor Cell; Pulmonary Metastasis; Colo-rectal Cancer

Keywords

Colo-rectal cancer; Lung metastasis; Radiofrequency ablation; Tumor infiltrating lymphocytes; Circulating tumor cells; Circulating DNA

Outcome Measures

Primary Outcomes (4)

• Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA1.

  Day 1

• Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA2.

  Week 6

• Immune Response Triggered by RFA: Quantification of Interaction of PD-1 and PD-L1 in Lung Metastases Using Immune Förster Resonance Energy Transfer (iFRET).

  Day 1

• Immune Response Triggered by RFA: Quantification of Interaction of PD-1 and PD-L1 in Lung Metastases Using Immune Förster Resonance Energy Transfer (iFRET).

  Week 6

Study Arms (1)

Single arm

EXPERIMENTAL

Each patient is treated with 2 RFA interventions.

Radiation: RFA interventions

Interventions

RFA interventions RADIATION

Each patient is treated with 2 RFA interventions. Abiopsy of one metastasis is done at each RF session. Histological samples are sent to the Bio-pathology department of Institut Bergonié for tumor infiltrating lymphocytes counting. Primary outcome results from this counting (stromal TILs ≥ 20% is considered as a significant level, a comparative measurement before and after RF will be performed). In parallel blood samples are performed before and after RFA to analyze the kinetics of peripheral blood T lymphocytes subsets, tumoral circulating cells and tumoral DNA.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 18 years-old.
• OMS performance status ≤ 2.
• Colorectal cancer histologically established previously.
• Primary tumor resected.
• Lung metastasis:
• Bilateral metastasis (or unilateral metastases that need to undergo the RF in two separate sessions due to the number of metastases ≥ 5)
• Maximal diameter ≤ 4 cm,
• non or slowly progressive, with or without chemotherapy,
• eligible to RFA.
• Thorax-abdomen-pelvis CT scan and PET scan:
• finding no more than 10 metastatic nodules (liver + lung or lung alone)
• Maximum of 8 weeks between the last cycle of chemotherapy and the first RFA.
• Decision of local treatment agreed at the multidisciplinary digestive tumor board.
• Life expectancy ≥ 3 months.
• Voluntarily signed and dated written informed consent prior to any study specific procedure.

You may not qualify if:

• Other than lung or liver metastases.
• Contraindication to general anesthesia.
• Contraindication to RFA: tumor location (\< 1cm from the hilum), lung insufficiency (FEV/sec \< 1l),
• Pregnant or lactating women.
• Concomitant participation to another interventional research.
• Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
• Patient deprived of liberty or under legal protection measure.

Sponsors & Collaborators

• Institut Bergonié: lead
• Groupement Interrégional de Recherche Clinique et d'Innovation: collaborator

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

Related Publications (1)

• Miles J, Soubeyran I, Marliot F, Pangon N, Italiano A, Bellera C, Ward SG, Pages F, Palussiere J, Larijani B. Determination of Interactive States of Immune Checkpoint Regulators in Lung Metastases after Radiofrequency Ablation. Cancers (Basel). 2022 Nov 22;14(23):5738. doi: 10.3390/cancers14235738.

  PMID: 36497220 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Neoplastic Cells, Circulating; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Pr Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

+33 5 56 33 33 33

Study Officials

• Jean PALUSSIERE, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: May 22, 2019
• Study Start: March 4, 2019
• Primary Completion: April 15, 2021
• Study Completion: March 15, 2022
• Last Updated: March 27, 2026
• Results First Posted: October 24, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)