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

A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Inclusion Criteria:

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

• Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment 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 laboratory requirements 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 too numerous to count)
• Pregnancy