Cervical Cancer Clinical Trial
— IMMUVIXOfficial title:
Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy (IMMUVIX)
Verified date | June 2023 |
Source | Institut du Cancer de Montpellier - Val d'Aurelle |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Perspectives: - To set-up another clinical trial with this specific phenotype as the main stratification factor. Therefore a more aggressive or a more specific systemic treatment (with or without an immunomodulator) could be proposed to those selected patients in the field of personalized medicine. - To evaluate the use of the smear as a surrogate non-invasive technique to biopsy for immunomonitoring. - To use the CTC/PD-L1 assay as a liquid biopsy in future clinical trials for stratification and monitoring of cancer patients undergoing immune checkpoint treatments. This specific subset of CTCs might represent metastatic cells with a high potential to escape T cell-mediated lysis and might therefore be the actual targets of immunotherapy.
Status | Active, not recruiting |
Enrollment | 29 |
Est. completion date | July 2024 |
Est. primary completion date | June 16, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years. - HPV-positive cervical cancer proven* by biopsy. - All FIGO stages cervical cancers which are the matter for radio-chemotherapy and exclusive brachytherapy indications. - ECOG performance status =2. - Ability to give informed consent. - Patients must be affiliated to a Social Security System. - Patient information and written informed consent form signed. Exclusion Criteria: - Adenocarcinoma of cervix. - Known autoimmune disorder. - History of HIV and/ or hepatitis infection. - History of pelvic radiation or radio-chemotherapy. - Recurrent or metastatic cervical cancer. - Contra-indication for cisplatin. - Patient pregnant and/or breastfeeding. - History of other malignancy within the previous 5 years (except for appropriately treated melanoma skin carcinoma). - Patients with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule |
Country | Name | City | State |
---|---|---|---|
France | CHRU Montpellier | Montpellier | |
France | Clinique Beausoleil | Montpellier | |
France | Moussin Aurore | Montpellier |
Lead Sponsor | Collaborator |
---|---|
Institut du Cancer de Montpellier - Val d'Aurelle |
France,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Expression of CD8+CD39+PD1+ lymphocytes infiltrate on cervix biopsies | Cervix biopsies analysis | through study completion, an average of 1 year disease free survival | |
Secondary | Effect on 1-year DFS of other putative biomarkers (CD73, CD39, PD1 and Tim3) on the non-regulatory CD4+ and CD8+ lymphocytes | Cervix biopsies and blood samples analysis | through study completion, an average of 1 year disease free survival |
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