Clinical trial · Interventional
Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin
Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin- ARFIM Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Biological analyses could not be performed (technical reasons related to the machine). As such, it was not possible to assess primary/secondary outcomes. No attempt will be made in the future to collect and/or report the data
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Immune Evasion, Tumor | — | UNRESOLVED | — |
| Neoplastic Cells, Circulating | — | UNRESOLVED | — |
| Pulmonary Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RFA interventions | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Each patient is treated with 2 RFA interventions.
- interventionNames
- Radiation: RFA interventions
Primary outcomes (4)
- measure
- Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA1.
- timeFrame
- Day 1
- measure
- Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA2.
- timeFrame
- Week 6
- measure
- Immune Response Triggered by RFA: Quantification of Interaction of PD-1 and PD-L1 in Lung Metastases Using Immune Förster Resonance Energy Transfer (iFRET).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient older than 18 years-old. 2. OMS performance status ≤ 2. 3. Colorectal cancer histologically established previously. 4. Primary tumor resected. 5. Lung metastasis: 1. Bilateral metastasis (or unilateral metastases that need to undergo the RF in two separate sessions due to the number of metastases ≥ 5) 2. Maximal diameter ≤ 4 cm, 3. non or slowly progressive, with or without chemotherapy, 4. eligible to RFA. 6. Thorax-abdomen-pelvis CT scan and PET scan: 1. performed within 8 weeks before inclusion 2. finding no more than 10 metastatic nodules (liver + lung or lung alone) 7. Maximum of 8 weeks between the last cycle of chemotherapy and the first RFA. 8. Decision of local treatment agreed at the multidisciplinary digestive tumor board. 9. Life expectancy ≥ 3 months. 10. Voluntarily signed and dated written informed consent prior to any study specific procedure. 11. Patients with a French social security in compliance with the Law relating to biomedical research (Article 1121-11 of French Public Health Code). Exclusion Criteria: 1. Other than lung or liver metastases. 2. Contraindication to general anesthesia. 3. Contraindication to RFA: tumor location (\< 1cm from the hilum), lung insufficiency (FEV/sec \< 1l), 4. Pregnant or lactating women. 5. Concomitant participation to another interventional research. 6. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons. 7. Patient deprived of liberty or under legal protection measure.
References
Publications (1)
- BACKGROUNDMiles 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