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RECRUITING
NCT04965454
PHASE2

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

Sponsor: Queen's Medical Center

View on ClinicalTrials.gov

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.

Official title: Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2022-03-28

Completion Date

2028-06-30

Last Updated

2025-05-01

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Queen's Medical Center

Honolulu, Hawaii, United States