Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 18 and over. 2. Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5). 3. Patients with no more than five lesions in dynamic contrast-enhanced CT or MRI, and the largest tumor diameter exceeding 8 cm. 4. Patients without vascular invasion and bile duct invasion in dynamic contrast-enhanced CT or MRI. 5. Patients with no extrahepatic metastasis in lung CT and contrast-enhanced abdominal CT or MRI. 6. Patients with no prior treatment for liver cancer. 7. Child-Pugh class A. 8. ECOG performance status of 1 or less. 9. Patients with no major organ dysfunction according to blood tests performed within one month of study enrollment. 1. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL 2. Absolute neutrophil count ≥ 1,500 /mm\^3 3. Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion) 4. Total bilirubin ≤ 3.0 mg/dL 5. Platelet ≥ 50,000/µL 6. INR ≤ 2.0 for patients not taking anticoagulants 7. AST ≤ 200 IU/L (