Recruiting NA Hepatocellular Carcinoma

New treatment option for Hepatocellular Carcinoma

Official title Liver Cancer and Immunotherapy in the Liquid Biopsy Era

ClinicalTrials.gov ID: NCT05810402

What this study is testing

What is Liquid Biopsy?

Liquid Biopsy is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.

Also referred to as Blood sample.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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?

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older. Healthy volunteers may be eligible.

You may be able to join 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...
  • 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 likely can't join 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 ;
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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.)

The study team makes the final eligibility decision.

Where it's taking place

  • Montpellier, France

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Montpellier, France. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.