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

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.

Inclusion Criteria: * Age 18 years or older (no upper limit of age) * Hepatocellular carcinoma diagnosis made histologically or radiographically in accordance to National Comprehensive Cancer Network guidelines (3.2019 version or higher) * Does not qualify for surgical resection or locoregional therapy alone or has disease that has progressed after surgical resection and/or locoregional therapy * Has measurable disease defined as at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on CT/MRI completed within past 6 weeks of eligibility screening * Under the care of a licensed medical oncologist * Life expectancy \> 6 months * Deemed eligible for treatment with an immune checkpoint inhibitor agent based on the treating medical oncologist's assessment of previous treatment failure, clinical/performance/virology status, and liver/renal/hematologic function. * Child-Pugh score of 9 or less * Creatinine clearance ≥ 40 mL/min, measured or calculated using the Cockcroft-Gault formula * ALT and AST ≤7x upper limit of normal * Total bilirubin ≤4 mg/dL * Albumin ≥2.8 g/dL Exclusion Criteria: * Weight \> 500 lbs (PET/CT limit) * Pregnant or lactating female (those of child-bearing potential must be re-screened within 7 days prior to PET/CT imaging) * Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure * Concurrent treatment with a non-targeted therapeutic agent. Concurrent enrollment in an ICI-treatment trial and combination ICI treatment are allowed.