Liver cancer immunotherapy guided by multi-omic liquid biopsy
Liver Cancer and Immunotherapy : Clinical Relevance of LIquid BioPSY
This project will test whether a multi-omic liquid biopsy can predict which adults with advanced (BCLC B or C) hepatocellular carcinoma will benefit from first-line PD-1/PD-L1 immunotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, atezolizumab, bevacizumab |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05810402 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center study enrolling adults with advanced HCC (BCLC stage B or C) who are candidates for first-line PD-1/PD-L1 immunotherapy and have not received prior systemic therapy. Blood samples will be collected at multiple time points and analyzed using a multi-omic liquid biopsy approach (circulating tumor cells with PD-L1, circulating tumor DNA, extracellular vesicles, microRNA, etc.). The study will compare liquid biopsy findings with tissue PD-L1 expression and treatment outcomes to identify predictive biomarkers of immunotherapy response. Results aim to clarify whether blood-based markers correlate with tumor tissue and can be used to guide treatment decisions.
Who should consider this trial
Good fit: Adults (≥18 years) with advanced hepatocellular carcinoma (BCLC stage B or C), no prior systemic anti-cancer therapy, and a planned first-line PD-1/PD-L1 immunotherapy who can provide informed consent are ideal candidates.
Not a fit: Patients who have received prior systemic anti-tumor therapy, have recent other cancers, active systemic inflammatory or immunosuppressive conditions, are pregnant, or cannot give informed consent are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the work could help doctors predict who will respond to immunotherapy and personalize treatment to improve outcomes and avoid ineffective therapy.
How similar studies have performed: Liquid-biopsy and multi-omic approaches have shown promise in other solid tumors, but reliable predictive biomarkers for immune checkpoint inhibitors in HCC remain largely unproven.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Montpellier
- CHU Montpellier — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Thomas Bardol, M.D. — University Hospital, Montpellier
- Study coordinator: Thomas Bardol, M.D.
- Email: t-bardol@chu-montpellier.fr
- Phone: +33682882757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.