Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
ExTRACT-HCC
Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma
2 other identifiers
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedStudy Start
First participant enrolled
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
May 1, 2025
April 1, 2025
5.8 years
July 7, 2021
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lack of Objective Response
Lack of Objective Response defined after 16 weeks as meeting criteria for either Stable Disease or Progressive Disease based on RECIST v1.1
16 weeks
Secondary Outcomes (2)
Objective Response
16 weeks
Disease Control
16 weeks
Study Arms (1)
Tested with Biomarkers
EXPERIMENTALFor 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.
Interventions
18F-fluorocholine is a radiopharmaceutical imaging agent intended for use only with positron emission tomography (PET) imaging. PET with in-line computed tomography imaging of the torso will be performed following intravenous administration of a single unit dose of this investigational new drug.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandi A Kwee, MD, PhD
The Queen's Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Director, PET Research
Study Record Dates
First Submitted
July 7, 2021
First Posted
July 16, 2021
Study Start
March 28, 2022
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
May 1, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- Starting 6 months after last publication at conclusion of the trial.
- Access Criteria
- Controlled-Access. Contact NIH dbGaP for more information.
Limited de-identified genomic and phenotypic individual participant data will be made available after the end of the trial via the NIH database of genotypes and phenotypes (dbGaP) in accordance with the NIH Genomic Data Sharing Policy. The individual level data made available by dbGaP is safeguarded by a process of controlled-access with data use limitations to be determined.