Building Evidence for Ablative Internal Radiation Therapy Using Yttrium-90 Glass Microspheres in Localized Hepatocellular Carcinoma Beyond the Up-To-7 Criteria

What this Trial Is About

Researchers are evaluating the use of ablative radioembolization with Yttrium-90 glass microspheres for patients with hepatocellular carcinoma (HCC) that exceeds the up-to-7 criteria but remains confined locally within up to five adjacent liver segments. This phase II, open-label study aims to assess the treatment's effectiveness and safety, focusing on tumor response measured by modified RECIST criteria. The trial is conducted at four major centers in Korea and sponsored by Seoul National University Hospital. All participants will receive personalized ablative radioembolization targeting a tumor dose of 700 Gy (±50%) using Yttrium-90 glass microspheres, with dosimetry planned by specialized software. For patients with high tumor burden, a second radioembolization may be performed within 180 days if lung dose limits are not exceeded. The treatment uses a glass-based radioactive microsphere delivery device called TheraSphere. Follow-up includes laboratory and imaging evaluations starting 4 weeks post-treatment and continuing every 3 months for 2 years. Participants will undergo regular assessments including tumor response evaluations by investigators and independent review, survival monitoring, and adverse event documentation according to established criteria. The study also tracks specific complications such as radioembolization-induced liver disease and radiation pneumonitis for 6 months after treatment. Overall, the study follows patients for up to 2 years to collect comprehensive data on treatment outcomes and safety.

Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria