Transarterial Chemoembolisation (TACE) Combined With Endovascular Implantation of Bare Stent and Iodine-125 Seed Strand for the Treatment of Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis Versus TACE Alone
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Median survival time
研究概览
简要总结
The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on CT or MRI;
- •(2) Child-Pugh classification grade A or B；
- •（3）Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
排除标准
- •advanced liver disease (bilirubin levels >3 mg/dL, ASTor ALT >5 × upper limit of normal)；
- •Tumor invade the Inferior Vena Cava, extrahepatic spread;
- •contraindications for doxorubicin or oxaliplatin chemotherapy;
- •any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
- •renal failure,cardiac ejection fraction <50 %) or end-stage disease；
- •patients who were not capable of cooperation during the procedure.
研究组 & 干预措施
TACE&Stents
chemoembolization combined with endovascular stents and iodine-125 seed strand implantation
干预措施: chemoembolization (Procedure)
TACE&Stents
chemoembolization combined with endovascular stents and iodine-125 seed strand implantation
干预措施: endovascular stents implantation (Device)
TACE&Stents
chemoembolization combined with endovascular stents and iodine-125 seed strand implantation
干预措施: iodine-125 seed strand implantation (Procedure)
TACE
Transartery chemoembolisation（TACE） by administering Doxorubicin and Oxaliplatin mixed with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.
干预措施: chemoembolization (Procedure)
结局指标
主要结局
Median survival time
时间窗: 2 years
次要结局
- Time to Disease Progression(2 years)
研究者
Zhiping Yan
Prof.
Shanghai Zhongshan Hospital