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.
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
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.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- 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
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- 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.
Objective Treatment Response Rate (ORR) per RECIST 1.1.
Measured: Baseline to first restaging imaging (~8-12 weeks).
Secondary outcomes (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.
- First posted7 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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