Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma

Official record

Identifier

NCT04965454

Recruiting locations

country

United States

Interventions studied

Fluorine-18 fluorocholine

Lead sponsor

Queen's Medical Center

Target enrolment

80 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Jul 16, 2021

Last updated on the registry

Aug 12, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Liver Cancer