Liver Cancer and Immunotherapy in the Liquid Biopsy Era
Recruiting now · Not applicable
Conditions studied: Hepatocellular Carcinoma, BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Immune Checkpoint Inhibitor, Liquid Biopsy
In brief
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.
Key facts
- Study ID
- NCT05810402
- Run by
- University Hospital, Montpellier
- People needed
- 60
- Starts
- 2023-06-28
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2025-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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.
- Non-inclusion due to follow-up difficulties (transfer, insufficient motivation, poor compliance, priority associated pathology in care, etc.)
Where it is running
- CHU Montpellier — Montpellier, France (enrolling)
Full record on ClinicalTrials.gov
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