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

Inclusion Criteria:

1. Adults aged 18 and over

2. Patients diagnosed with unilobar hepatocellular carcinoma, either histologicallyand/or radiologically (LI-RADS 4 or 5)

3. Patients with at least one measurable lesion greater than 10 mm on dynamiccontrast-enhanced CT or MRI

4. Patients with localized portal vein invasion limited in one lobe (Vp1-3) on dynamiccontrast-enhanced CT or MRI

5. Patients with no extrahepatic metastasis on lung CT and contrast-enhanced abdominalCT or MRI

6. Patients with no prior treatment for liver cancer

7. Child-Pugh class A

8. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less

9. Patients without serious dysfunction of major organs, as indicated by blood testsconducted within one month of study enrollment

10. Leukocytes ≥ 2,500/µL and ≤ 12,000/µL

11. Absolute neutrophil count ≥ 1,500/mm^3

12. Hemoglobin ≥ 8.0 g/dL (transfusions allowed to meet this criterion)

13. Total bilirubin ≤ 3.0 mg/dL

14. Platelets ≥ 50,000/µL

15. For patients not on anticoagulants, INR ≤ 2.0

16. AST ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)

17. ALT ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)

18. ALP ≤ 575 IU/L (i.e., ≤ 5X upper normal limit)

19. Creatinine ≤ 2.0 mg/dL

20. Patients with a life expectancy of more than 3 months

21. Patients who have fully understood the clinical trial and given written consent

22. Female patients of childbearing age confirmed not to be pregnant

Exclusion Criteria:

1. Patients unsuitable for ablative radioembolization as per the pre-test withmacro-aggregated albumin labeled with technetium-99 (99mTc-MAA) forradioembolization.

2. Cases where, according to multi-compartment Medical Internal Radiation Dosemethod, delivering 205 Gy of radiation to the tumor exceeds an estimated lungdose of 25 Gy.

3. Cases with severe hepatic artery-portal vein shunting leading to expectedirradiation of the non-tumorous opposite lobe.

4. Patients whose volume of non-tumorous liver not included in the treatment area isless than 30% of the total non-tumorous liver volume.

5. Patients with hepatic vein or bile duct invasion as seen on dynamiccontrast-enhanced CT or MRI.

6. Patients scheduled to use immunotherapy regardless of the response toradioembolization.

7. Patients who had active cancer within two years prior to joining the clinical trial.

8. Patients who have undergone surgery or procedures related to the bile duct.

9. Pregnant or breastfeeding women.