Evaluating biomarkers for predicting treatment response in liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of PET/CT imaging and genomic liquid biopsy as predictors of response to immune-checkpoint inhibitor therapy in patients with inoperable hepatocellular carcinoma (HCC). Participants will undergo diagnostic testing with fluorine-18 fluorocholine (FCH) PET/CT and cell-free DNA mutation profiling before starting treatment. The study will evaluate the accuracy of these biomarkers in predicting therapeutic outcomes and disease progression after 16 weeks of treatment. The results will be based on objective clinical endpoints using established radiographic classification methods.

Why it matters

Who can join: the full rules

Inclusion 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 screening
* 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 liver/renal/hematologic function.
* 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

Exclusion Criteria:

* 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.

Where it's running

• The Queen's Medical Center
  Honolulu, Hawaii, United States Recruiting

Study contacts

• Principal investigator: Sandi A Kwee, MD, PhD — The Queen's Medical Center
• Study coordinator: Abrar M Al-Adhmi, BS
• Email: aaadhmi@queens.org
• Phone: 808-691-7429

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.