NCT05810402 Liver Cancer and Immunotherapy in the Liquid Biopsy Era
| NCT ID | NCT05810402 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-06-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-06-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.)
Contact & Investigator
Catherine Alix-Panabières, Ph.D.
STUDY DIRECTOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT05810402 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05810402 currently recruiting?
Yes, NCT05810402 is actively recruiting participants. Contact the research team at t-bardol@chu-montpellier.fr for enrollment information.
Where is the NCT05810402 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT05810402 clinical trial?
NCT05810402 is sponsored by University Hospital, Montpellier. The principal investigator is Catherine Alix-Panabières, Ph.D. at University Hospital, Montpellier. The trial plans to enroll 60 participants.
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