Study design
tumor, extrahepatic disease, toxicity, HCC, non-segmental, tumors
TUMOR, METASTASIS, LIVER, SECONDARY, ONCOLOGY, TUMORS
In a prospective single-arm clinical trial (NCT04172714), which evaluated the efficacy of low/scout activity of resin-based Y90 for treatment planning, the secondary aim of the study was to determine dose thresholds for treatment response and toxicity. The study was approved by the local institutional review board and is Health Insurance Portability and Accountability Act compliant. From December 2019 to January 2021, eligible participants with treatment-naïve HCC were recruited after obtaining informed written consent. All participants recruited were deemed to potentially benefit from Y90 radioembolization for downstaging therapy or as definitive therapy by the local institutional multidisciplinary tumor board.Inclusion criteria were adults deemed to benefit from Y90, presence of HCC confirmed by Liver Reporting and Data System (LIRADS) on CT or MRI or biopsy, less than or equal to 3 lesions confined to a single lobe, targeted tumors measuring ≥ 2 cm and ≤ 8 cm, absence of extrahepatic metastasis, Eastern Cooperative Oncology Group (ECOG) status ≤ 2, and life expectancy ≥ 6 months.Required laboratory values were bilirubin < 2 mg/dL for non-segmental therapy or < 3 mg/dL for segmental therapy, albumin > 3 g/dL, international normalized ratio (INR) < 2, AST/ALT three times the upper limits of normal, and platelet count > 50,000/mcL.Exclusion criteria were patients who were found to have extrahepatic disease during mapping, those who had a lung shunt fraction that would result in dose modification and cause inadequate tumoral dose, and those with a history of systemic or liver-directed therapy for HCC.