RECRUITINGINTERVENTIONAL

Liver Cancer and Immunotherapy in the Liquid Biopsy Era

Liver Cancer and Immunotherapy : Clinical Relevance of LIquid BioPSY

About This Trial

The goal of this prospective clinical trial is to identify a predictive biomarker in patients with advanced HCC (stage B and C) using a combinatorial approach of the liquid biopsy. The main questions it aims to answer are: * Is multi-omic liquid biopsy approach able to identify a strong predictive biomarker of immunotherapy efficiency? * Is there a correlation between tissue biopsy (PD-L1 tissue level of expression) and liquid biopsy (detection of CTC expressing PD-L1) in HCC patients? Participants blood will be collected at several time points.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients of at least 18 years old, - Patients with advanced hepatocellular carcinoma or HCC with indication for first-line PD-1 or PD-L1 immunotherapy in MDT, without previous cancer treatment that works throughout the body (like chemotherapy), - The diagnosis of HCC is established according to imaging criteria (LI-RADSv2018 criteria) or after histological evidence, - Advanced HCC defined by BCLC stages B and C, - Patients with oral consent. Who Should NOT Join This Trial: - Administration of a previous systemic anti-tumor treatment (immunotherapy or chemotherapy or targeted therapy) - No personal history of neoplasia in the previous 5 years - No personal history of systemic inflammatory diseases - No immunosuppressive treatment or treatment that could modify immunity (anti-TNF...) - No affiliation or non-beneficiary of a Social Security system; - Vulnerable persons according to article L1121-6 of the CSP ; - Persons of full age who are protected or unable to give their consent according to article L1121-8 of the CSP; - Pregnant or breastfeeding women according to article L1121-5 of the CSP. - Non-inclusion due to follow-up difficulties (transfer, insufficient motivation, poor compliance, priority associated pathology in care, etc.) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients of at least 18 years old, * Patients with advanced hepatocellular carcinoma or HCC with indication for first-line PD-1 or PD-L1 immunotherapy in MDT, without prior systemic therapy, * The diagnosis of HCC is established according to imaging criteria (LI-RADSv2018 criteria) or after histological evidence, * Advanced HCC defined by BCLC stages B and C, * Patients with oral consent. Exclusion Criteria: * Administration of a previous systemic anti-tumor treatment (immunotherapy or chemotherapy or targeted therapy) * No personal history of neoplasia in the previous 5 years * No personal history of systemic inflammatory diseases * No immunosuppressive treatment or treatment that could modify immunity (anti-TNF...) * No affiliation or non-beneficiary of a Social Security system; * Vulnerable persons according to article L1121-6 of the CSP ; * Persons of full age who are protected or unable to give their consent according to article L1121-8 of the CSP; * Pregnant or breastfeeding women according to article L1121-5 of the CSP. * Non-inclusion due to follow-up difficulties (transfer, insufficient motivation, poor compliance, priority associated pathology in care, etc.)

Treatments Being Tested

BIOLOGICAL

Liquid Biopsy

30mL blood sample: * 1 x 10mL CellSave tube specifically designed for the collection and preservation of CTCs for CellSearch® analysis * 1 EDTA tube for PBMCs isolation and circulating immune cells study (5mL), * 2 EDTA tubes and 1 dry tube (15mL) for the preparation of the biobank (serum, plasma and cell).

Locations (1)

CHU Montpellier

Montpellier, France