STRATHEP: AI-Driven Treatment Stratification for Advanced Hepatocellular Carcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Objective Treatment Response Rate (ORR) per RECIST 1.1.

Time frame
Baseline to first restaging imaging (~8-12 weeks).

Secondary outcomes

1

Progression-Free Survival (PFS)

Time frame
collected for a maximum of 5 years per patient

Other outcomes

Sponsors and contacts

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