Liver Cancer and Immunotherapy in the Liquid Biopsy Era
NCT ID: NCT05810402
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-06-28
2027-05-31
Brief Summary
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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.
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Detailed Description
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Hepatocellular carcinoma (HCC) is the predominant pathological type of primary liver cancer. It represents the sixth most common incidence worldwide and the third most common cause of cancer mortality.
Since 2021, the gold standard treatment for patients with advanced and/or unresectable HCC is the combination of atezolizumab (anti-PD-L1) and bevacizumab (VEGF inhibitor) in cases where chemoembolization is not indicated (patients with lymph node invasion and/or distant lesions or patients with portal flow abnormality). Indeed, this therapy offers a significant benefit in overall survival (19.2 vs 13.4 months, HR 0.66, p\<0.0009) as well as in progression-free survival (6.9 vs 4.3 months, HR 0.65, p=0.0001). However, to date, there is no predictive biomarker for the efficacy of immune checkpoint inhibitors (ICI)
The purpose of this research project is to identify a predictive biomarker in patients with advanced HCC (stage B and C) using a combinatorial approach of the liquid biopsy (CTC, CTC expressing PD-L1, immune cell profiling).
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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BCLC B and C HCC patients
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.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
18 Years
ALL
Yes
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Catherine Alix-Panabières, Ph.D.
Role: STUDY_DIRECTOR
University Hospital, Montpellier
Thomas Bardol, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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CHU Montpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Thomas BARDOL, M.D.
Role: primary
References
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Other Identifiers
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RECHMPL22_0514
Identifier Type: -
Identifier Source: org_study_id
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