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Liver Cancer and Immunotherapy in the Liquid Biopsy Era

RECRUITINGN/ASponsored by University Hospital, Montpellier
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Montpellier
Started2023-06-28
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Non-inclusion due to follow-up difficulties (transfer, insufficient motivation, poor compliance, priority associated pathology in care, etc.)

Conditions8

BCLC Stage B Hepatocellular CarcinomaBCLC Stage C Hepatocellular CarcinomaCancerHepatocellular CarcinomaImmune Checkpoint InhibitorLiquid BiopsyLiver CancerLiver Disease

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