Immune Evasion, TumorARFIMNCT03960021
Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin
A study testing RFA interventions in people with Immune Evasion, Tumor and Neoplastic Cells, Circulating, run by Institut Bergonié at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Evasion, Tumor, Neoplastic Cells, Circulating, Circulating Tumor Cell
- What is being tested?
- RFA interventions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2019to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- Maximal diameter ≤ 4 cm,
- non or slowly progressive, with or without chemotherapy,
- eligible to RFA.
- Thorax-abdomen-pelvis CT scan and PET scan:
- performed within 8 weeks before inclusion
- 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.
- Patients with a French social security in compliance with the Law relating to biomedical research (Article 1121-11 of French Public Health Code).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin- ARFIM Study
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.
Read the detailed description
RFA could provide activatory signals and become a source of tumor antigens for the immune system. Generating a massive and transient release of antigens, RFA could boost lymphocyte proliferation and production of inflammatory cytokines in response to tumor extracts. Herein, the investigator aims to demonstrate that RFA can amplify the specific T cell response in metastatic cancer patients. In order to ensure this, he plans to assess and quantify tumor infiltrating lymphocytes through tumoral biopsies. He also plans to measure the CD4, CD8 and NK lymphocytes release, the circulating DNA and tumoral cells release, during RFA of lung metastases. On tumoral biopsies, the expression of PDL-1 ligand will also be evaluated and measured. Participants with bilateral metastases or with 5 or more unilateral metastases will be recruited. The two RFA interventions will be carried out within 4-6 weeks of each other. Blood samples and tumoral biopsies will be performed during each intervention. Biopsies will be performed on a metastasis before the thermal ablation. Blood samples will be performed just before RFA, 30 min after RFA and one day after. Analysis, identification and measure of lymphocytes release will be performed with flow cytometry. All analysis and measurements will be performed in the Bio-Pathology department of Institut Bergonié.
- Conditions
- Immune Evasion, Tumor, Neoplastic Cells, Circulating, Circulating Tumor Cell, Pulmonary Metastasis, Colo-rectal Cancer
- Being tested
- RFA interventions
- Keywords
- Colo-rectal cancer, Lung metastasis, Radiofrequency ablation, Tumor infiltrating lymphocytes, Circulating tumor cells, Circulating DNA
- Medical subject headings
- Neoplasms, Neoplastic Cells, Circulating, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA interventionsRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Each patient is treated with 2 RFA interventions. Receives: Radiation: RFA interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA1.
Measured: Day 1
Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA2.
Measured: 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).
Measured: 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).
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start4 Mar 2019
- Primary completion15 Apr 2021
- Study completion15 Mar 2022
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Evasion, TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Jean PALUSSIERE, MD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960021
- Sponsor's protocol ID
- IB 2018-03
- Other IDs
- 2018-A01996-49
- Acronym
- ARFIM
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2019
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36497220
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin- ARFIM Study
- ClinicalTrials.gov ID
- NCT03960021
- Acronym / sponsor ID
- ARFIM / IB 2018-03
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RFA could provide activatory signals and become a source of tumor antigens for the immune system. Generating a massive and transient release of antigens, RFA could boost lymphocyte proliferation and production of inflammatory cytokines in response to tumor extracts. Herein, the investigator aims to demonstrate that RFA can amplify the specific T cell response in metastatic cancer patients. In order to ensure this, he plans to assess and quantify tumor infiltrating lymphocytes through tumoral biopsies. He also plans to measure the CD4, CD8 and NK lymphocytes release, the circulating DNA and tumoral cells release, during RFA of lung metastases. On tumoral biopsies, the expression of PDL-1 ligand will also be evaluated and measured. Participants with bilateral metastases or with 5 or more unilateral metastases will be recruited. The two RFA interventions will be carried out within 4-6 weeks of each other. Blood samples and tumoral biopsies will be performed during each intervention. Biopsies will be performed on a metastasis before the thermal ablation. Blood samples will be performed just before RFA, 30 min after RFA and one day after. Analysis, identification and measure of lymphocytes release will be performed with flow cytometry. All analysis and measurements will be performed in the Bio-Pathology department of Institut Bergonié.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Radiation: RFA interventionsEach patient is treated with 2 RFA interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient older than 18 years-old.
- OMS performance status ≤ 2.
- Colorectal cancer histologically established previously.
- Primary tumor resected.
- Lung metastasis:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFA interventionsEach 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. | Radiation | Single arm |
Primary outcome
Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA1.
Time frame: Day 1
Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA2.
Time frame: 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).
Time frame: 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).
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36497220Miles 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean PALUSSIERE, MD principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA interventions in people with Immune Evasion, Tumor and Neoplastic Cells, Circulating, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA1. (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.