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New treatment option for Hepatocellular Carcinoma Non-resectable
Official title Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT04965454
What this study is testing
What is Fluorine-18 fluorocholine?
Fluorine-18 fluorocholine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma non-resectable.
Also referred to as 18F-fluorocholine, Fluorocholine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Does not qualify for surgical resection or locoregional therapy alone or has disease that has progressed after surgical resection and/or locoregional...
- Has measurable disease defined as at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumors...
- Under the care of a licensed medical oncologist
You likely can't join if
- 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.
See the full 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Honolulu, Hawaii, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Honolulu, Hawaii, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.