An Open-label, Prospective, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Ablative Radioembolization Using Yttrium-90 Glass Microspheres in Patients With Locally-advanced Hepatocellular Carcinoma
The RESOLVE trial, an open-label, single-arm, multi-center study, aims to assess the efficacy and safety of ablative radioembolization using TheraSphere Yttrium-90 microspheres. This trial specifically targets patients diagnosed with hepatocellular carcinoma accompanied by localized portal vein tumor thrombosis (Vp1-Vp3) and who maintain good liver function.
• Adults aged 18 and over
• Patients diagnosed with unilobar hepatocellular carcinoma, either histologically and/or radiologically (LI-RADS 4 or 5)
• Patients with at least one measurable lesion greater than 10 mm on dynamic contrast-enhanced CT or MRI
• Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamic contrast-enhanced CT or MRI
• Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominal CT or MRI
• Patients with no prior treatment for liver cancer
• Child-Pugh class A
• Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
• Patients without serious dysfunction of major organs, as indicated by blood tests conducted within one month of study enrollment
∙ Leukocytes ≥ 2,500/µL and ≤ 12,000/µL
‣ Absolute neutrophil count ≥ 1,500/mm\^3
‣ Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion)
‣ Total bilirubin ≤ 3.0 mg/dL
‣ Platelets ≥ 50,000/µL
‣ For patients not on anticoagulants, INR ≤ 2.0
‣ AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
‣ ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
‣ ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit)
∙ Creatinine ≤ 2.0 mg/dL
⁃ Patients with a life expectancy of more than 3 months
⁃ Patients who have fully understood the clinical trial and given written consent
⁃ Female patients of childbearing age confirmed not to be pregnant