Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis

Prior treatment

• Patients scheduled to use immunotherapy regardless of the response to radioembolization.
• Patients who had active cancer within two years prior to joining the clinical trial.
• Patients who have undergone surgery or procedures related to the bile duct.

Lab values

• Patients unsuitable for ablative radioembolization as per the pre-test with macro-aggregated albumin labeled with technetium-99 (99mTc-MAA) for radioembolization.
  • Cases where, according to multi-compartment Medical Internal Radiation Dose method, delivering 205 Gy of radiation to the tumor exceeds an estimated lung dose of 25 Gy.
  • Cases with severe hepatic artery-portal vein shunting leading to expected irradiation of the non-tumorous opposite lobe.

Other

• Patients whose volume of non-tumorous liver not included in the treatment area is less than 30% of the total non-tumorous liver volume.
• Patients with hepatic vein or bile duct invasion as seen on dynamic contrast-enhanced CT or MRI.
• Pregnant or breastfeeding women.

• 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