Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)

Inclusion criteria

• Measurable disease defined as at least one unidimensional measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).
• Must have at least one lesion > 2 cm within the target perfused volume.
• At least one lesion must meet the definition of target lesion as defined by RECIST 1.1 or mRECIST.
• Total linear length of all lesions must be ≤ 9 cm.
• Must have preservation of >700cc of normal liver parenchyma outside of treated volume.
• Hypervascular lesions on CT scan with 99mTC MAA SPECT/CT T:N ratio 3:1 or higher and Hypervascular on CBCT.
• No prior locoregional therapies in the liver other than previous Drug Eluting Bead TACE and/or local HCC recurrence after thermal ablation. Last TACE and/or ablation treatment must be at least 3 months prior to informed consent. Prior Lumi or Lipiodol TACE is not allowed.
• Life expectancy of ≥ 6 months.
• ≥ 18 years old.

Exclusion criteria

• Hemoglobin ≤ 85 mg/L.
• Platelet count < 50,000/microliter or prothrombin (PT) activity > 50% normal
• INR > 1.4 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
• ALT > 2.5x upper limit
• AST > 2.5x upper limit
• For HCC subjects, Bilirubin ≥ 2 mg/dL.
• For mCRC subjects, Bilirubin ≥ 1.2 mg/dL.
• eGFR ≤ 60 mL/min/1.73 m2.
• Portal vein thrombosis (PVT).
• Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater
• Estimated lung dose > 30 Gy as calculated using the lung shunt % and partition model.