NCT04965454RecruitingPhase 2
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 7 Jul 2021
- Start date
- 28 Mar 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Queen's Medical Center
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04965454
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 28 Mar 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant or lactating female (those of child-bearing potential must be re-screened within 7 days prior to PET/CT imaging)
- Concurrent treatment with a non-targeted therapeutic agent. Concurrent enrollment in an ICI-treatment trial and combination ICI treatment are allowed.
Other illness
- Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
Other
- Weight \> 500 lbs (PET/CT limit)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Queen's Medical Center Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.