Randomized Study of Therasphere 90-Yittrium Transarterial Radioembolization Versus Microwave Ablation in Small Hepatocellular Carcinoma With Hypoalbuminemia

What this Trial Is About

This clinical trial is studying patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma HCC. It aims to compare outcomes between two liver-directed treatments to see if 90-Yittrium Therasphere transarterial radioembolization 90Y reduces the risk of disease progression within one year after diagnosis. The focus is on patients with a single tumor 3 cm or smaller and albumin levels below 3.4 gdL at diagnosis. Participants are randomly assigned to receive either 90Y or microwave ablation MWA as their first liver-directed therapy. The 90Y treatment involves a two-phase process including a mapping angiogram with personalized dosimetry followed by infusion of 90-Yittrium glass microspheres targeting the tumor area. The MWA uses a high-powered, gas-cooled multi-antenna system to ablate the tumor with an ablative margin greater than 5 mm. After this initial treatment, participants continue with standard care for early-stage HCC. Throughout the study, participants are followed for one year after their first treatment cycle. Researchers will collect data on adverse events, treatment response, time to any retreatment, duration of response, and disease progression. The main measure is disease progression at one year, with additional evaluations done 60 to 120 days after treatment. This monitoring helps assess the safety and effects of the two treatments over time.

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