Improving Immunotherapy Use in Liver Cancer

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 multicenter, low-intervention study collects tumor tissue and blood samples from adults with hepatocellular carcinoma to identify biomarkers that predict immunotherapy sensitivity. It uses archival and prospective samples to map the tumor microenvironment and T-cell receptor relationships between blood and tumor tissue. No experimental drugs are given; patient management remains standard of care, and samples are taken during routine procedures. The study includes three cohorts totaling 300 patients and aims to improve patient selection for systemic or local therapies based on biomarker findings.

Why it matters

Who can join: the full rules

* General inclusion Criteria:

  1. Male or female, age \> 18 years
  2. Diagnosis or suspected diagnosis of hepatocellular carcinoma based on imaging
* Specific inclusion criteria cohort 1 (retrospective/prospective data may be applicable):

  1. Pathologically confirmed HCC
  2. Treated with systemic treatment \[tyrosine kinase inhibitor (TKI) or immunotherapy (ICI)\] in the last 7 years and follow-up data (at least one imaging on treatment) available until 01/01/2025
  3. Biopsy obtained between 01/01/2018 until 01/01/2025
  4. Left-over tissue from previous diagnostic biopsies or resection specimens available
  5. Time between biopsy and initiation of systemic treatment \< 1 year
  6. Ability to sign informed consent for secondary use of archival tissue and data collection for study-specific research for patients who are alive
* Specific inclusion criteria cohort 2 (aHCC \& prospective):

  1. Suspicion of hepatocellular carcinoma (imaging criteria or recurrent disease of previously treated HCC)
  2. Indication for tumor biopsy per standard of care
  3. Eligible for systemic treatment (any) after pathological confirmation of HCC
  4. Ability to sign informed consent for primary use of tissue and blood samples and data collection for study-specific research
* Specific inclusion criteria cohort 3 (eHCC \& prospective):

  1. Suspicion of hepatocellular carcinoma (imaging criteria or recurrent disease of previously treated HCC)
  2. Indication for local treatment (resection or ablation)
  3. Ability to sign informed consent for primary use of tissue and blood samples and for data collection for study-specific research

     Due to the observational nature of this study, participation in other (interventional) clinical trials is permitted, if biological materials can be collected per protocol.
* General exclusion criteria:

  1. Poor liver function and/or performance status which prohibits active treatment
  2. Pathologically proven other malignancies of the liver, including primary cholangiocarcinoma or liver metastases
  3. Treatment plan other than systemic treatment or local treatment (resection or ablation), such as TACE, TARE, liver transplantation

Where it's running

• Uza
  Antwerp, Belgium Recruiting
• Jessa ziekenhuis
  Hasselt, Belgium Recruiting
• AZ Groeninge
  Kortrijk, Belgium Recruiting
• AZ Delta
  Roeselare, Belgium Recruiting

Study contacts

• Study coordinator: Jeroen Dekervel, MD
• Email: jeroen.dekervel@uzleuven.be
• Phone: 016344225

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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.