A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 102
Inclusion Criteria
- Infiltrative type & unilobular involvement on liver MRI
- Age : 20 years to 80 years
- Absolute neutrophil count > 500/mm3
- ...
- Infiltrative type & unilobular involvement on liver MRI
- Age : 20 years to 80 years
- Absolute neutrophil count > 500/mm3
- Single & 5cm < size < 15cm
- Hb ≧ 7.0 g/dL
- Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
- ECOG Performance Status of 0 to 2
- Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
- Bilirubin ≦ 3 mg/dL
- Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
- Platelet count > 100,000 /mm3
- Adequate clotting function: INR ≦ 2.3 or ≦ 6sec
- Segmental or lobar portal vein invasion can be included.
- 2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm
- WBC count ≧ 1,000/mm3
Exclusion Criteria
- Patients who have received prior systemic chemotherapy
- Child-Pugh score ≧ 8
- Bilobar involvement
- ...
- Patients who have received prior systemic chemotherapy
- Child-Pugh score ≧ 8
- Bilobar involvement
- Patients with uncontrolled co-morbidity which needs treatment
- Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules too numerous to count)
- History of organ allograft
- Patients who have received Capecitabine within 8 weeks
- Patients with lymph node metastasis
- Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
- ECOG Performance Status ≧ 3
- Patients with extrahepatic metastasis
- Pregnancy
- Main portal vein invasion
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
- Infiltrative type & unilobular involvement on liver MRI
- Age : 20 years to 80 years
- Absolute neutrophil count > 500/mm3
- ...
- Infiltrative type & unilobular involvement on liver MRI
- Age : 20 years to 80 years
- Absolute neutrophil count > 500/mm3
- Single & 5cm < size < 15cm
- Hb ≧ 7.0 g/dL
- Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
- ECOG Performance Status of 0 to 2
- Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
- Bilirubin ≦ 3 mg/dL
- Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
- Platelet count > 100,000 /mm3
- Adequate clotting function: INR ≦ 2.3 or ≦ 6sec
- Segmental or lobar portal vein invasion can be included.
- 2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm
- WBC count ≧ 1,000/mm3
Exclusion Criteria
- Patients who have received prior systemic chemotherapy
- Child-Pugh score ≧ 8
- Bilobar involvement
- ...
- Patients who have received prior systemic chemotherapy
- Child-Pugh score ≧ 8
- Bilobar involvement
- Patients with uncontrolled co-morbidity which needs treatment
- Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules too numerous to count)
- History of organ allograft
- Patients who have received Capecitabine within 8 weeks
- Patients with lymph node metastasis
- Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
- ECOG Performance Status ≧ 3
- Patients with extrahepatic metastasis
- Pregnancy
- Main portal vein invasion
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
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