Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
Recruiting now · Phase 2
Conditions studied: Hepatocellular Carcinoma Non-resectable
In brief
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.
Key facts
- Study ID
- NCT04965454
- Run by
- Queen's Medical Center
- People needed
- 80
- Starts
- 2022-03-28
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2025-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Queen's Medical Center — Honolulu, Hawaii, United States (enrolling)
Full record on ClinicalTrials.gov
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