Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma

Who is this study for? Patients with hepatocellular carcinoma
What treatments are being studied? Fluorine-18 fluorocholine
Status: Recruiting
Location: See location...
Intervention Type: Combination Product
Study Type: Interventional
Study Phase: Phase 2

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.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• 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)

• Barcelona Clinic Liver Cancer Stage B or C

• 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 7 or less

• Creatinine clearance ≥ 40 mL/min, measured or calculated using the Cockcroft-Gault formula

• ALT and AST ≤5x upper limit of normal

• Total bilirubin ≤3 mg/dL

• Albumin ≥2.8 g/dL

United States
The Queen's Medical Center
Contact Information
Miles M Sato, MS, MPH
Tim Kelleher, RN
Time Frame
Start Date: March 28, 2022
Estimated Completion Date: December 31, 2026
Target number of participants: 80
Experimental: Tested with Biomarkers
For this single arm study, all enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before treatment involving an immune checkpoint inhibitor agent. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake.
Related Therapeutic Areas
Leads: Queen's Medical Center
Collaborators: National Cancer Institute (NCI)

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