Actively Recruiting
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
Led by Queen's Medical Center · Updated on 2025-05-01
80
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
Sponsors
Q
Queen's Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (no upper limit)
- Diagnosis of hepatocellular carcinoma confirmed by histology or imaging as per NCCN guidelines
- Cancer is not suitable for surgery or locoregional therapy alone, or has progressed after such treatments
- At least one measurable tumor lesion per RECIST v1.1 on CT or MRI within 6 weeks prior to screening
- Under care of a licensed medical oncologist
- Life expectancy greater than 6 months
- Eligible for immune checkpoint inhibitor treatment based on oncologist assessment
- Child-Pugh score of 9 or less
- Creatinine clearance 40 mL/min or higher
- ALT and AST levels less than or equal to 7 times the upper limit of normal
- Total bilirubin less than or equal to 4 mg/dL
- Albumin level 2.8 g/dL or higher
You will not qualify if you...
- Weight over 500 lbs (PET/CT limit)
- Pregnant or breastfeeding women (must be re-screened if of childbearing potential within 7 days before PET/CT)
- Serious medical conditions impairing ability to tolerate imaging
- Receiving treatment with non-targeted therapies concurrently (except enrollment in ICI treatment trials and combination ICI therapy allowed)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Actively Recruiting
Research Team
A
Abrar M Al-Adhmi, BS
CONTACT
T
Tim Kelleher, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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