Clinical Trial

Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma

Study acronym: ExTRACT-HCC
Recruiting Phase 2
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Summary
This prospective clinical trial will evaluate PET/CT and genomic liquid biopsy based biomarkers as predictors of clinical therapeutic response to immune-checkpoint inhibitor (ICI) therapy for patients with inoperable hepatocellular carcinoma (HCC). The primary objective of this diagnostic trial is to assess the accuracy of pre-treatment fluorine-18 (18F-) fluorocholine (FCH) PET/CT for predicting a lack of objective response (LOR) after 16 weeks of ICI therapy.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-07-07; most recent amendment 2025-04-28.
Status change: Not Yet Recruiting → Recruiting 2022-03-28
Trial Details
NCT Number NCT04965454
Lead Sponsor Queen's Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Hepatocellular Carcinoma Non-resectable
Enrollment 80 participants
Start Date 2022-03-28
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-12