Liver Cancer and Immunotherapy in the Liquid Biopsy Era

NCT05810402 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-10

No results posted yet for this 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.

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05810402 on ClinicalTrials.gov