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

Inclusion Criteria:

• Must have a confirmed diagnosis of HCC by imaging confirmation with Liver ImagingReporting 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) measurableby computed tomography (CT), CBCT, or MRI. At least one lesion must be identified asa target lesion as defined by mRECIST.

• Maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12cm 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 sparedEye90 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 medicalmanagement must be excluded).

• INR > 1.7 (if anticoagulated, reversal must be achieved prior to any angiographicprocedures).

• 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 compromisedAmpulla of Vater.

• Estimated lung dose > 30 Gy as calculated using the lung shunt fraction andpartition model.