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

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.

Eligibility

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.

Conditions4

Locations1 site

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