A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Seoul National University Hospital
- Locations
- 1
- Primary Endpoint
- Overall survival
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed 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 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.
Investigators
Jung-Hwan Yoon
Professor
Seoul National University Hospital
Eligibility Criteria
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)
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
Outcomes
Primary Outcomes
Overall survival
Time Frame: every 12 weeks, up to the time of death, up to 12 months
From date of randomization until the date of death
Secondary Outcomes
- Progression-Free Survival in the Liver(every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months)
- Progression-Free Survival Overall(every 12 weeks, up to the time of death or first documented progression, up to 12 months)
- Overall tumor response assessment(every 12 weeks, up to the time of death or 12 months)