Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)

Fecha de inicio: 21 de septiembre de 2023

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.