Liver Cancer and Immunotherapy in the Liquid Biopsy Era
Liver Cancer and Immunotherapy : Clinical Relevance of LIquid BioPSY
University Hospital, Montpellier
60 participants
Jun 28, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria9
- 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.)
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT05810402