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Recruiting Not applicable

Liver Cancer and Immunotherapy in the Liquid Biopsy Era

NCT05810402 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-06-28
Last updated
2025-07-10

Condition(s) studied

Hepatocellular CarcinomaBCLC Stage B Hepatocellular CarcinomaBCLC Stage C Hepatocellular CarcinomaImmune Checkpoint InhibitorLiquid Biopsy

Investigational drug(s) / intervention(s)

Liquid Biopsy

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).

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.)

Primary outcome measure(s)

  • Percentage of patients with CTCs-PD-L1+ by CellSearch® technique — At inclusion
    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

Trial sites (1)

FacilityCityRegionStatus
CHU Montpellier Montpellier France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05810402 on ClinicalTrials.gov ↗ ← All trials in France