Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)

Launched by ABK BIOMEDICAL · Jul 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of Eye90 microspheres, a special medical device that delivers targeted radiation to treat liver tumors in patients with a specific type of liver cancer called hepatocellular carcinoma (HCC). The trial aims to find out how effective and safe this treatment is for patients whose tumors cannot be surgically removed. Participants must be adults who have been diagnosed with HCC and have certain characteristics, such as having up to three liver tumors with at least one measuring 2 cm or more. They also need to have a good amount of healthy liver tissue remaining.

People who join this trial can expect to receive treatment in a single session where the Eye90 microspheres will be delivered directly to their tumors. To be eligible, participants should be at least 18 years old and have a life expectancy of six months or more. However, individuals with certain health issues, like low blood counts or liver problems, may not qualify. This trial is currently recruiting participants, and it offers a potential new option for those with liver cancer who have limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Must have a confirmed diagnosis of HCC by imaging confirmation with Liver Imaging Reporting and Data System (LIRADS) category 5 or confirmation of HCC via biopsy.
• • No extra hepatic disease.
• • Up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable by computed tomography (CT), CBCT, or MRI. At least one lesion must be identified as a target lesion as defined by mRECIST.
• • Maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12 cm with the entire tumor burden expected to be treatable within the perfused volume.
• • Intent to treat all lesions within a single session.
• • Hypervascular on CBCT, CT, or MRI.
• • Evidence that \> 33% of the total liver volume is disease-free and will be spared Eye90 treatment.
• • Life expectancy of ≥ 6 months.
• • ≥ 18 years old at the time of informed consent
• Exclusion Criteria:
• • Platelet count \<50,000/microliter or prothrombin (PT) activity \> 50% normal.
• • Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical management must be excluded).
• • INR \> 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
• • ALT \> 5x upper limit.
• • AST \> 5x upper limit.
• • Bilirubin ≥ 2.0 mg/dL.
• • eGFR ≤ 50 mL/min/BSA.
• • Macrovascular invasion.
• • Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater.
• • Estimated lung dose \> 30 Gy as calculated using the lung shunt fraction and partition model.