A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma

Inclusion Criteria:

• Patients with clinical or histological diagnosis of HCC based on the guidelines of theAJCC

• Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4segment or left lobe ± S4 segment)

• Patients with single large HCC or multinodular HCC

• Single & 5cm < size < 15cm

• 2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm

• Infiltrative type & unilobular involvement on liver MRI

• Segmental or lobar portal vein invasion can be included.

• Age : 20 years to 80 years

• ECOG Performance Status of 0 to 2

• Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)

• Adequate bone marrow, liver function as assessed by the following laboratoryrequirements to be conducted within 7 days prior to screening:

• WBC count ≧ 1,000/mm3

• Absolute neutrophil count > 500/mm3

• Hb ≧ 7.0 g/dL

• Platelet count > 100,000 /mm3

• Bilirubin ≦ 3 mg/dL

• Adequate clotting function: INR ≦ 2.3 or ≦ 6sec

Exclusion Criteria:

• Child-Pugh score ≧ 8

• ECOG Performance Status ≧ 3

• Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL

• History of organ allograft

• Patients with uncontrolled co-morbidity which needs treatment

• Patients who have received prior systemic chemotherapy

• Patients who have received Capecitabine within 8 weeks

• Patients with extrahepatic metastasis

• Main portal vein invasion

• Patients with lymph node metastasis

• Bilobar involvement

• Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules toonumerous to count)

• Pregnancy