RecruitingHepatocellular Carcinoma Non-resectable
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Queen's Medical Center
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
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's recruiting
Hawaii
Honolulu
Source: ClinicalTrials.gov · NCT04965454 · last updated 2025-05-01