Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Or… (NCT03960021) | Clinical Trial Compass
TerminatedNot Applicable
Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin
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
France20 participantsStarted 2019-03-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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,
Exclusion criteria
✕. Other than lung or liver metastases.
✕. Contraindication to general anesthesia.
✕. Contraindication to RFA: tumor location (\< 1cm from the hilum), lung insufficiency (FEV/sec \< 1l),
What they're measuring
1
Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA1.
Timeframe: Day 1
2
Immune Response Triggered by RFA: Change From Rate of Tumor Infiltrating T Lymphocytes on Tumoral Stroma Measured Before and After RFA2.
Timeframe: Week 6
3
Immune Response Triggered by RFA: Quantification of Interaction of PD-1 and PD-L1 in Lung Metastases Using Immune Förster Resonance Energy Transfer (iFRET).
Timeframe: Day 1
4
Immune Response Triggered by RFA: Quantification of Interaction of PD-1 and PD-L1 in Lung Metastases Using Immune Förster Resonance Energy Transfer (iFRET).