RECRUITING

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

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Conditions

Hepatocellular Carcinoma Non-resectablehepatocellular carcinomaimmunotherapypositron emission tomographymutation profilingliquid biopsypersonalized medicinediagnosticfluorocholineimmune checkpoint inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma

Quick Facts

Study Start:2022-03-28
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04965454

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older (no upper limit of age)
  2. * Hepatocellular carcinoma diagnosis made histologically or radiographically in accordance to National Comprehensive Cancer Network guidelines (3.2019 version or higher)
  3. * Does not qualify for surgical resection or locoregional therapy alone or has disease that has progressed after surgical resection and/or locoregional therapy
  4. * 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
  5. * Under the care of a licensed medical oncologist
  6. * Life expectancy \> 6 months
  7. * 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.
  8. * Child-Pugh score of 9 or less
  9. * Creatinine clearance ≥ 40 mL/min, measured or calculated using the Cockcroft-Gault formula
  10. * ALT and AST ≤7x upper limit of normal
  11. * Total bilirubin ≤4 mg/dL
  12. * Albumin ≥2.8 g/dL
  1. * Weight \> 500 lbs (PET/CT limit)
  2. * Pregnant or lactating female (those of child-bearing potential must be re-screened within 7 days prior to PET/CT imaging)
  3. * Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
  4. * Concurrent treatment with a non-targeted therapeutic agent. Concurrent enrollment in an ICI-treatment trial and combination ICI treatment are allowed.

Contacts and Locations

Study Contact

Miles M Sato, MS, MPH
CONTACT
808-691-8584
msato@queens.org
Tim Kelleher, RN
CONTACT
808-691-8582
tkelleher@queens.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Queen's Medical Center

  • Sandi A Kwee, MD, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2022-03-28
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-03-28
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • hepatocellular carcinoma
  • immunotherapy
  • positron emission tomography
  • mutation profiling
  • liquid biopsy
  • personalized medicine
  • diagnostic
  • fluorocholine
  • immune checkpoint inhibitor

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma Non-resectable