Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05810402

Liver Cancer and Immunotherapy in the Liquid Biopsy Era

Led by University Hospital, Montpellier · Updated on 2025-07-10

60

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Liver Cancer and Immunotherapy in the Liquid Biopsy Era

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Diagnosis of HCC established by imaging criteria (LI-RADSv2018) or histological evidence
  • Advanced HCC defined by BCLC stages B and C
  • Patients able to give oral consent
Not Eligible

You will not qualify if you...

  • Previous systemic anti-tumor treatment (immunotherapy, chemotherapy, or targeted therapy)
  • Personal history of neoplasia within the last 5 years
  • Personal history of systemic inflammatory diseases
  • Receiving immunosuppressive treatment or therapy that could modify immunity (e.g., anti-TNF)
  • Not affiliated with or not a beneficiary of a Social Security system
  • Vulnerable persons as defined by article L1121-6 of the CSP
  • Adults who are protected or unable to give consent according to article L1121-8 of the CSP
  • Pregnant or breastfeeding women according to article L1121-5 of the CSP
  • Inability to comply with follow-up due to transfer, poor motivation, compliance issues, or priority associated pathology

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Montpellier

Montpellier, France

Actively Recruiting

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Research Team

T

Thomas Bardol, M.D.

CONTACT

C

Catherine Guillemare

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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