Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma (ExTRACT-HCC)

April 28, 2025 updated by: Sandi Kwee, Queen's Medical Center

Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective open-label single-arm diagnostic clinical trial evaluating fluorine-18 fluorocholine (FCH) PET/CT and cell-free DNA mutation profiling (also referred to as genomic liquid biopsy) as diagnostic tools for predicting therapeutic response in advanced HCC patients receiving immune-checkpoint inhibitor (ICI) therapy. All enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before ICI treatment. 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. The accuracy of tumor biomarkers based on PET/CT and liquid biopsy for predicting therapeutic outcome and disease progression will be determined using objective clinical endpoints based on the radiographic classification of treatment response by RECIST v1.1 applied to CT or MRI performed after 16 weeks of treatment.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • The Queen's Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandi A Kwee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tested with Biomarkers
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.
Combination product: Fluorine-18 fluorocholine
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.
Other Names:
  • Fluorocholine
  • FCH
  • 18F-fluorocholine
  • 18F-FCH
  • [18F]fluorocholine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lack of Objective Response
Time Frame: 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response
Time Frame: 16 weeks
Objective Response defined after 16 weeks as meeting criteria for either Partial Response or Complete Response based on RECIST v1.1
16 weeks
Disease Control
Time Frame: 16 weeks
Disease Control defined after 16 weeks as meeting criteria for either Partial Response, Complete Response, or Stable Disease based on RECIST v1.1
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sandi A Kwee, MD, PhD, The Queen's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA-2021-018
  • R01CA262460 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Starting 6 months after last publication at conclusion of the trial.

IPD Sharing Access Criteria

Controlled-Access. Contact NIH dbGaP for more information.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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