Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
102

Inclusion Criteria

Segmental or lobar portal vein invasion can be included.
Platelet count > 100,000 /mm3
Hb ≧ 7.0 g/dL
...
Segmental or lobar portal vein invasion can be included.
Platelet count > 100,000 /mm3
Hb ≧ 7.0 g/dL
ECOG Performance Status of 0 to 2
Infiltrative type & unilobular involvement on liver MRI
WBC count ≧ 1,000/mm3
Absolute neutrophil count > 500/mm3
Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
Single & 5cm < size < 15cm
Bilirubin ≦ 3 mg/dL
Age : 20 years to 80 years
Adequate clotting function: INR ≦ 2.3 or ≦ 6sec
Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm

Exclusion Criteria

History of organ allograft
Patients with uncontrolled co-morbidity which needs treatment
Patients with lymph node metastasis
...
History of organ allograft
Patients with uncontrolled co-morbidity which needs treatment
Patients with lymph node metastasis
Child-Pugh score ≧ 8
Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules too numerous to count)
Patients who have received Capecitabine within 8 weeks
Pregnancy
Main portal vein invasion
Patients who have received prior systemic chemotherapy
Bilobar involvement
Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
Patients with extrahepatic metastasis
ECOG Performance Status ≧ 3

Summary

Conditions
Hepatocellular Carcinoma
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 80 years
Gender
Both males and females

Description

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 patie...

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

Segmental or lobar portal vein invasion can be included.
Platelet count > 100,000 /mm3
Hb ≧ 7.0 g/dL
...
Segmental or lobar portal vein invasion can be included.
Platelet count > 100,000 /mm3
Hb ≧ 7.0 g/dL
ECOG Performance Status of 0 to 2
Infiltrative type & unilobular involvement on liver MRI
WBC count ≧ 1,000/mm3
Absolute neutrophil count > 500/mm3
Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
Single & 5cm < size < 15cm
Bilirubin ≦ 3 mg/dL
Age : 20 years to 80 years
Adequate clotting function: INR ≦ 2.3 or ≦ 6sec
Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm

Exclusion Criteria

History of organ allograft
Patients with uncontrolled co-morbidity which needs treatment
Patients with lymph node metastasis
...
History of organ allograft
Patients with uncontrolled co-morbidity which needs treatment
Patients with lymph node metastasis
Child-Pugh score ≧ 8
Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules too numerous to count)
Patients who have received Capecitabine within 8 weeks
Pregnancy
Main portal vein invasion
Patients who have received prior systemic chemotherapy
Bilobar involvement
Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
Patients with extrahepatic metastasis
ECOG Performance Status ≧ 3

Tracking Information

NCT #
NCT02004210
Collaborators
Not Provided
Investigators
  • Principal Investigator: Jung-Hwan Yoon, M.D., Ph.D. Seoul National University Hospital
  • Jung-Hwan Yoon, M.D., Ph.D. Seoul National University Hospital