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Hepatocellular Carcinoma (HCC)STRATHEPNCT07863258

STRATHEP: AI-Driven Treatment Stratification for Advanced Hepatocellular Carcinoma

An observational study of Hepatocellular Carcinoma (HCC), run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

STRATHEP develops and validates a multimodal AI model to predict treatment response in advanced hepatocellular carcinoma. By integrating digital pathology and MRI radiomics, the project identifies patients likely to benefit from modern systemic therapies, using the RECIST 1.1 framework as the primary benchmark. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma (HCC)
How many people
280 participants
Where
5 sitesBelgium
Study dates
15 Oct 2026to Dec 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with hepatocellular carcinoma (HCC) who received systemic therapy.

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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jeroen Dekervel, MD PhD contact

+3216344225

jeroen.dekervel@uzleuven.be

Sofie De Meulder, MD contact

+3216344225

Sofie.DeMeulder@azdelta.be

5 sites in 1 country

Belgium5 sites, 5 recruiting

  • Hôpital Universitaire de Bruxelles

    Anderlecht, 1070

    Gontran Verset, MD, +32 2 555 55 55, gontran.verset@hubruxelles.be

    Gontran Verset, MD

    Recruiting

  • Imelda Ziekenhuis

    Bonheiden, 2820

    Pieter-Jan Cuyle, MD, +3215 50 56 91, pieter-jan.cuyle@imelda.be

    Pieter-Jan Cuyle, MD

    Recruiting

  • AZ Sint-Lucas Brugge

    Bruges, 8310

    Annelies Holvoet, MD, +3250365155, Annelies.Holvoet@stlucas.be

    Annelies Holvoet, MD

    Recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

    Timon Vandamme, MD PhD, +32 3 821 33 23, Timon.Vandamme@uza.be

    Timon Vandamme, MD PhD

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

About this study

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

STRATHEP develops and validates a multimodal AI model to predict treatment response in advanced hepatocellular carcinoma. By integrating digital pathology and MRI radiomics, the project identifies patients likely to benefit from modern systemic therapies, using the RECIST 1.1 framework as the primary benchmark.

Keywords
Artificial Intelligence, Digital Pathology, Immune Checkpoint Inhibitors, Predictive Biomarkers, Hepatocellular Carcinoma, Machine Learning, Digitalization
Medical subject headings
Carcinoma, Hepatocellular

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Treatment Response Rate (ORR) per RECIST 1.1.

    Measured: Baseline to first restaging imaging (~8-12 weeks).

Secondary outcomes (1)

  1. Progression-Free Survival (PFS)

    Measured: collected for a maximum of 5 years per patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07863258
Sponsor's protocol ID
S71399
Acronym
STRATHEP
Status last verified
Sep 2026
First submitted
1 Oct 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma (HCC), run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeroen Dekervel, MD PhD (+3216344225, jeroen.dekervel@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Treatment Response Rate (ORR) per RECIST 1.1. (time frame: Baseline to first restaging imaging (~8-12 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07863258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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