A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Overall survival
时间窗: every 12 weeks, up to the time of death, up to 12 months
From date of randomization until the date of death
次要结局
- 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)
研究者
Jung-Hwan Yoon
Professor
Seoul National University Hospital