Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma Non-resectable | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorine-18 fluorocholine | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tested with Biomarkers
- description
- 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.
- interventionNames
- Combination Product: Fluorine-18 fluorocholine
Primary outcomes (1)
- measure
- Lack of Objective Response
- timeFrame
- 16 weeks
- description
- Lack of Objective Response defined after 16 weeks as meeting criteria for either Stable Disease or Progressive Disease based on RECIST v1.1
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available