An Open-label, Single-arm, Single-center Clinical Trial to Evaluate the Efficacy and Safety of Yttrium-90 Ablative Radioembolization (Radiation Major Hepatectomy) for Unifocal Large Hepatocellular Carcinoma
The RESCUE trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of ablative radioembolization using Yttrium-90. This treatment is being investigated as a potential curative approach, as well as a bridging or downstaging strategy for surgery, in patients with large hepatocellular carcinoma (greater than 8 cm) who maintain good liver function.
• Adults aged 18 and over.
• Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5).
• Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm.
• Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI.
• Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI.
• Patients with no prior treatment for liver cancer.
• Child-Pugh class A.
• ECOG performance status of 1 or less.
• Patients with no major organ dysfunction according to blood tests performed 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 (transfusion allowed to meet this criterion)
‣ Total bilirubin ≤ 3.0 mg/dL
‣ Platelet ≥ 50,000/µL
‣ INR ≤ 2.0 for patients not taking anticoagulants
‣ 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 adequately understood the clinical trial and consented in writing.
⁃ Non-pregnant women of childbearing potential.