Clinical Trial of Biomarkers for Predicting Immunotherapy Response 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.
• 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