Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Treatments: Cisplatin

Criteria

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