STRATHEP: AI-Driven Treatment Stratification for Advanced Hepatocellular Carcinoma

NCT07863258 — Recruiting, 280 participants, Universitaire Ziekenhuizen KU Leuven

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Treatment STRATification in Patients With Advanced HEPatocellular Carcinoma (STRATHEP)

Registry	NCT07863258, acronym STRATHEP
Status	Recruiting
Study type	Observational
Enrollment	280 (Estimated)
Sponsor	Universitaire Ziekenhuizen KU Leuven (Other)
Conditions	Hepatocellular Carcinoma (HCC)
Dates	start 2026-10-15 (estimated), primary completion 2027-12-01 (estimated), completion 2031-12-01 (estimated), first posted 2026-10-07, last updated 2026-10-07
Locations	5 sites in Belgium

-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.

Expand all sections · Collapse all

+Outcome measures

Primary outcomes

Objective Treatment Response Rate (ORR) per RECIST 1.1. [Baseline to first restaging imaging (~8-12 weeks).]

Secondary outcomes

Progression-Free Survival (PFS) [collected for a maximum of 5 years per patient]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (5)

Facility	City	Country	Status
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