Clinical trial Recruiting at 5 sites Observational Ages 18 and up

AI-guided treatment choices for advanced liver cancer

Official title: Treatment STRATification in Patients With Advanced HEPatocellular Carcinoma (STRATHEP)

Run by Universitaire Ziekenhuizen KU Leuven · NCT07863258 · Data updated 2026-11-12

Researchers are testing an AI tool to help predict which patients with advanced hepatocellular carcinoma will respond to modern systemic therapies.

More Hepatocellular Carcinoma (HCC) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment280 (estimated)
SponsorUniversitaire Ziekenhuizen KU Leuven
Academic / other
Locations5 sites (Anderlecht and 4 other locations)
StatusRecruiting
StartedOctober 15, 2026
Main results expectedDecember 2027
Study endsDecember 2031
Registry record updatedOctober 7, 2026
Trial IDNCT07863258 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with hepatocellular carcinoma who have been treated with systemic therapy and have appropriate tissue or MRI data available for analysis.

Probably not a fit

Patients without archival tissue or suitable imaging data, or those not receiving systemic therapy, may not benefit from this predictive approach.

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

What this trial studies

This observational study develops and validates a multimodal artificial intelligence model that combines digital pathology and MRI radiomics to predict treatment response in advanced hepatocellular carcinoma. The model uses RECIST 1.1 as the primary benchmark for assessing responses to systemic therapies. The study leverages archival tissue and imaging data, aiming to identify patients most likely to benefit from current systemic options. Participating sites include several major hospitals in Belgium, with data collected under informed consent for secondary use. No interventional treatment is described within the protocol itself; the focus is on predictive modeling and validation.

Why it matters

Potential benefit: If successful, the model could help tailor systemic therapy choices for patients with advanced HCC by predicting who is most likely to respond.

How similar studies have gone: Past work in similar AI-based predictive approaches for cancer treatment responses has shown promise, but integration of digital pathology with MRI radiomics for HCC is an emerging area.

Who can join: the full rules

Show full inclusion / exclusion criteria
Participants eligible for inclusion in this Study must meet all of the following criteria:

* Male or female, age \> 18 years
* Hepatocellular carcinoma treated with systemic treatment during the disease course
* Histological confirmation of HCC within one year of the start of systemic treatment OR the availability of an MRI of the liver within 6 months of the start of systemic treatment
* Left-over tissue from previous diagnostic biopsy available
* Ability to sign informed consent for secondary use of archival tissue and data collection for study-specific research for patients who are alive and that have not yet reached a 5-year follow-up period.

Participants eligible for this Study must not meet any of the following criteria:

* Hepatocellular carcinoma not treated systemically
* Other malignancies of the liver, including cholangiocarcinoma

Where it's running

  • Hôpital Universitaire de Bruxelles
    Anderlecht, Belgium
    Recruiting
  • Imelda Ziekenhuis
    Bonheiden, Belgium
    Recruiting
  • AZ Sint-Lucas Brugge
    Bruges, Belgium
    Recruiting
  • Universitair Ziekenhuis Antwerpen
    Edegem, Belgium
    Recruiting
  • UZ Leuven
    Leuven, Belgium
    Recruiting

Study contacts

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.