RECRUITING

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

Description

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

Study Details

Study overview

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.

Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma

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

Condition
Hepatocellular Carcinoma Non-resectable
Intervention / Treatment

-

Contacts and Locations

Honolulu

The Queen's Medical Center, Honolulu, Hawaii, United States, 96813

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Queen's Medical Center,

Sandi A Kwee, MD, PhD, PRINCIPAL_INVESTIGATOR, The Queen's Medical Center

Study Record Dates

2027-12-31