RecruitingPhase 2NCT04965454

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

Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma

Sponsor

Queen's Medical Center

Enrollment

80 participants

Start Date

Mar 28, 2022

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Non-resectable

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether certain molecular features of liver cancer — specifically involving a pathway called beta-catenin — can predict how well patients respond to immunotherapy drugs. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with liver cancer (hepatocellular carcinoma), confirmed by tissue biopsy or imaging - Your cancer cannot be fully removed by surgery alone, or it has come back after surgery or local treatment - You have at least one measurable tumour on a CT or MRI scan done within the past 6 weeks - You are under the care of a licensed cancer doctor - You have a life expectancy of more than 6 months - Your doctor considers you suitable for immunotherapy (immune checkpoint inhibitor) treatment **You may NOT be eligible if...** - You are not a candidate for immunotherapy - Your tumour cannot be measured on imaging - Your overall health is too poor for study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTFluorine-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.