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.
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,
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...)
Single group
Liquid Biopsy
Biological/Vaccine30mL 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).
Percentage of patients with CTCs-PD-L1+ by CellSearch® technique
A CTC is being defined as: EpCAM(+)/PanCK(+)/Dapi(+)/CD45(-). The PD-L1 status will be observed only on these cells. CTC-PD-L1- = 0 vs CTC-PD-L1+ ≥1
Number of CTCs-PD-L1+ measured by CellSearch® technique
0 vs. 1 vs. 2-3 vs. 4 vs. ≥5
Presence of CTCs at inclusion by CellSearch® technique
Percentage of patients with CTCs
Number of CTCs measured by CellSearch® technique
0 vs 1 vs 2-3 vs 4 vs ≥5
Immune profiling
FACS study of immune system cells (T cells, NK cells, B cells, macrophages, immune-checkpoint and platelets)
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