Liver cancer immunotherapy guided by multi-omic liquid biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.