Liver Cancer and Immunotherapy in the Liquid Biopsy Era
NCT05810402 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-07-10
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.
Conditions
- Hepatocellular Carcinoma
- BCLC Stage B Hepatocellular Carcinoma
- BCLC Stage C Hepatocellular Carcinoma
- Immune Checkpoint Inhibitor
- Liquid Biopsy
Interventions
- 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).
Sponsors & Collaborators
-
University Hospital, Montpellier
lead OTHER
Principal Investigators
-
Catherine Alix-Panabières, Ph.D. · University Hospital, Montpellier
-
Thomas Bardol, M.D. · University Hospital, Montpellier
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-28
- Primary Completion
- 2026-12-31
- Completion
- 2027-05-31
Countries
- France
Study Locations
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