This clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will determine whether treatment with 90Y lowers the risk of disease progression within the first year after diagnosis. Participants will be randomized to receive either first cycle 90Y or MWA and then proceed with standard of care.
HCC diagnosis according to the Liver Imaging - Reporting Data System (LI-RADS) Criteria as defined in the American Association for the Study of Liver Diseases 2018 HCC practice guidelines
Eastern Cooperative Oncology Group score 0 - 1
Child-Pugh A - B
Bilirubin < 2.5 mg/dL
Pregnant women
Concurrent malignancy
Parallel
Therasphere 90Y
DeviceTransarterial Radioembolization
Microwave Ablation
DeviceMicrowave Ablation
Disease Progression
Progression in disease staging according to the Barcelona Clinic Liver Cancer Staging Algorithm
Target Response Evaluation Criteria in Solid Tumors modified for HCC
Durable target tumor response rate
Time to Retreatment
Duration of time following the first cycle treatment until the targeted tumor requires additional treatment
Duration of Response
Duration of time after first cycle treatment the target tumor continues to respond to treatment
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Ochsner Health System
Lead sponsor
Boston Scientific Corporation
Collaborator
