What this Trial Is About

Researchers are investigating the use of ablative radioembolization with Yttrium-90 resin microspheres to treat patients with large hepatocellular carcinoma tumors greater than 8 cm in size who have good liver function. This single-arm, phase 2 clinical trial aims to evaluate the safety and effectiveness of this treatment as a potential cure or as a way to prepare patients for surgery by shrinking the tumor. The study is focused on patients with unifocal liver cancer without vascular or bile duct invasion and no spread outside the liver. The treatment involves delivering a high radiation dose directly to the tumor and surrounding liver margin using Yttrium-90 microspheres guided by detailed imaging and dose modeling. The goal is to treat the entire tumor with one or two treatment sessions while keeping radiation exposure to the lungs and healthy liver within safe limits. The procedure is personalized based on lung dose constraints and liver volume to preserve at least 30% of healthy liver tissue. Participants will be followed for up to two years to assess tumor response using imaging criteria, safety, and duration of treatment effect. Assessments include blood tests, imaging scans, and clinical evaluations to monitor liver function, tumor status, and overall health. Safety monitoring will continue for 90 days after treatment, and participants must provide informed consent and meet strict eligibility requirements including liver function and blood count thresholds.

Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma