Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen's Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fluorine-18 fluorocholine
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Queen's Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov