Building Evidence for Ablative Internal Radiation Therapy Using Yttrium-90 Glass Microspheres in Localized Hepatocellular Carcinoma Beyond the Up-To-7 Criteria
At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Their treatment response, survival outcomes, and adverse events will be monitored for two years following the procedure.
• Adult aged 19 and over
• HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease
• Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors \> 7
• Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments
• No current or previous HCC in the untreated liver (i.e., future liver remnant \[FLR\])
• FLR volume \> 30% of total non-tumorous liver volume
• Child-Pugh class A
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• No major organ dysfunction according to blood test performed within two months of study enrollment:
‣ Leukocytes ≥ 2,000/µL and ≤ 15,000/µL
⁃ Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion)
⁃ Total bilirubin ≤ 2.0 mg/dL
⁃ Platelet ≥ 40,000/µL
⁃ International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants
⁃ Aspartate transaminase (AST) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
⁃ Alanine transaminase (ALT) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
⁃ Creatinine ≤ 2.5 mg/dL
• Patients with a life expectancy of more than 3 months
• For women of childbearing age, a negative serum pregnancy test
• Patients who have adequately understood the clinical trial and consented in writing