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

Launched by QUEEN'S MEDICAL CENTER · Jul 7, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at ways to predict how well patients with inoperable liver cancer, known as hepatocellular carcinoma (HCC), will respond to a specific type of treatment called immune checkpoint inhibitors (ICIs). Researchers want to know if a special imaging test called PET/CT, along with a blood test that checks for certain genetic markers, can accurately indicate whether patients will respond positively to the ICI therapy after 16 weeks. This study aims to help doctors better understand which patients are more likely to benefit from this treatment.

To participate in the trial, patients must be at least 18 years old and have a confirmed diagnosis of liver cancer that cannot be treated with surgery. They should have measurable tumors and be under the care of a medical oncologist. Other health criteria, like liver function and kidney health, also need to be met. If eligible, participants can expect to undergo imaging and blood tests to help guide their treatment, while also receiving the ICI therapy. The trial is currently recruiting participants, so it's a great opportunity for those who meet the criteria to potentially benefit from this innovative research.

Gender

ALL

Eligibility criteria

• 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.