Colo-rectal Cancer Clinical Trial
— ARFIMOfficial title:
Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin- ARFIM Study
Verified date | February 2024 |
Source | Institut Bergonié |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 15, 2022 |
Est. primary completion date | April 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Institut Bergonie | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
Institut Bergonié | Groupement Interrégional de Recherche Clinique et d'Innovation |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immune response triggered by RFA: Change from rate of tumor infiltrating T lymphocytes on tumoral stroma measured before and after RFA1. | Day 1 | ||
Primary | Immune response triggered by RFA: Change from rate of tumor infiltrating T lymphocytes on tumoral stroma measured before and after RFA2. | Week 6 | ||
Primary | 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 | ||
Primary | 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 2 | ||
Primary | 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 | ||
Secondary | Immune response triggered by RFA: Distribution of blood factors related to the immune response of the kinetics of peripheral blood T lymphocytes subsets NK, CD4, CD8 and their activated receptor subgroups HLADR+, CD25+, CD38+ release before RFA1. | Day 1 | ||
Secondary | Immune response triggered by RFA: Change from baseline (before RFA1) blood factors related to the immune response of the kinetics of peripheral blood T lymphocytes subsets NK, CD4, CD8. | Day 1 | ||
Secondary | Immune response triggered by RFA: Change from baseline (before RFA1) blood factors related to the immune response of the kinetics of peripheral blood T lymphocytes subsets NK, CD4, CD8. | Day 2 | ||
Secondary | Immune response triggered by RFA: Change from baseline (before RFA2) blood factors related to the immune response of the kinetics of peripheral blood T lymphocytes subsets NK, CD4, CD8. | Week 6 | ||
Secondary | Rate of Circulating DNA and tumor cells. | Day 1 | ||
Secondary | Rate of Circulating DNA and tumor cells. | Day 2 | ||
Secondary | Rate of Circulating DNA and tumor cells. | Week 6 | ||
Secondary | Expression of PDL-1 ligand on tumor cells from biopsies. | Day 1 | ||
Secondary | Expression of PDL-1 ligand on tumor cells from biopsies. | Week 6 | ||
Secondary | Change from baseline size of RFA treated tumor sites at 3 months based on CT scanner. | Month 3 | ||
Secondary | Change from baseline size of RFA treated tumor sites at 6 months based on CT scanner. | Month 6 | ||
Secondary | Change from baseline size of RFA treated tumor sites at 9 months based on CT scanner. | Month 9 | ||
Secondary | Change from baseline size of RFA treated tumor sites at 12 months based on CT scanner. | Month 12 | ||
Secondary | Change from baseline metastatic disease at 3 months | Month 3 | ||
Secondary | Change from baseline metastatic disease at 6 months | Month 6 | ||
Secondary | Change from baseline metastatic disease at 9 months | Month 9 | ||
Secondary | Change from baseline metastatic disease at 12 months | Month 12 |
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