Health TrialsbyHealthPanel

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

ConditionHepatocellular Carcinoma Non-resectable
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen's Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fluorine-18 fluorocholine

    Combination product

    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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Tested with BiomarkersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Lack of Objective Response

Lack of Objective Response defined after 16 weeks as meeting criteria for either Stable Disease or Progressive Disease based on RECIST v1.1

Time frame
16 weeks

Secondary outcomes

1

Objective Response

Objective Response defined after 16 weeks as meeting criteria for either Partial Response or Complete Response based on RECIST v1.1

Time frame
16 weeks
2

Disease Control

Disease Control defined after 16 weeks as meeting criteria for either Partial Response, Complete Response, or Stable Disease based on RECIST v1.1

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen's Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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