90Y Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

This study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (HCC) who are candidates for both 90-Yittrium Therasphere transarterial radioembolization (90Y) and microwave ablation (MWA). The study will focus on patients with solitary, small HCC, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of HCC diagnosis, defined as albumin < 3.4 g/dL. Participants will be randomized to receive either 90Y or MWA as a first cycle liver-directed therapy.

The study will enroll 50 participants randomized at a 1:1 ratio to 90Y or MWA. After first cycle treatment, the participants will resume standard of care management for early-stage HCC. Participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.

Inclusion criteria

• 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
• Creatinine < 2.0 mg/dL
• No prior liver-directed therapy or systemic therapy for HCC
• Solitary, unresectable HCC ≤ 3cm
• Albumin level < 3.4 g/dL at HCC diagnosis
• Tumor anatomical location and angiosome amendable to MWA and 90Y

Exclusion criteria

• Pregnant women
• Concurrent malignancy