Liver Cancer and Immunotherapy in the Liquid Biopsy Era

NCT05810402 | Recruiting

• 1 other identifier: RECHMPL22_0514
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hepatocellular Carcinoma; BCLC Stage B and C; Immune Checkpoint Inhibitor; Liquid Biopsy; Precision Medicine

Outcome Measures

Primary Outcomes (1)

• 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

  At inclusion

Secondary Outcomes (9)

• Number of CTCs-PD-L1+ measured by CellSearch® technique

  At inclusion

• Presence of CTCs at inclusion by CellSearch® technique

  At inclusion

• Number of CTCs measured by CellSearch® technique

  At inclusion

• Immune profiling

  24 month follow up

• Expression of PD-L1 by immuno-histochemical analysis of tissue samples

  At inclusion

Study Arms (1)

BCLC B and C HCC patients

EXPERIMENTAL

For each participant, 30mL of blood will be collected at inclusion/before treatment initiation (baseline) and during standard of care follow-up. The blood sample will be taken, in consultation or in outpatient clinic during a blood test for health purposes.

Biological: Liquid Biopsy

Interventions

Liquid Biopsy BIOLOGICAL

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).

Also known as: Blood sample

BCLC B and C HCC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, France

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Liquid Biopsy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Catherine Alix-Panabières, Ph.D.

  University Hospital, Montpellier

  STUDY DIRECTOR

• Thomas Bardol, M.D.

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Bardol, M.D.

CONTACT

+33682882757; t-bardol@chu-montpellier.fr

Catherine Guillemare

CONTACT

+33467332304; c-guillemare@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Homogenous cohort of BCLC Stage B and C hepatocellular carcinoma patients that will undergo immunotherapy +/- anti-angiogenic agent (bevacizumab)

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: June 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)