Endovascular Brachytherapy Combined With Stent Placement and Transcatheter Arterial Chemoembolization (TACE) for Treatment of HCC With Main Portal Vein Tumor Thrombus Versus TACE Alone: a Prospective Randomized Controlled Multicentre Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and endovascular brachytherapy combined with stent placement and TACE for HCC with main portal vein tumor thrombus.
详细描述
It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Zhi-ping Yan.Investigators in twenty-seven hospitals in China participate in.Patients with unresectable HCC with main portal vein tumor thrombus are enrolled. The investigators propose to recruitment 253 patients who are randomly assigned into the combined group (treated with endovascular brachytherapy combined with stent placement and TACE) and the control group (treated with TACE alone).There are 127 patients in combined group and 126 patients in control group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.
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
- 18 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;
- •(2) According to the Barcelona Clinic Liver Cancer staging classification, HCC was unsuitable for resection, liver transplantation or percutaneous radiofrequency ablation;
- •(3) Tumor thrombus, a low-attenuation intraluminal filling defect extending from intrahepatic portal vein branches adjacent to primary tumor into main portal vein, was confirmed by contrast-enhanced abdominal computer tomography (CT) or magnetic resonance imaging (MRI)
- •(4) At least the first-order branch of the intrahepatic portal vein was patent in one lobe;
- •(5) Child-Pugh classification grade A or B;
- •(6) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;
排除标准
- •(1) Patients had a history of any therapy for HCC or portal vein tumor thrombus;
- •(2) Advanced liver disease (bilirubin levels >3 mg/dL, Aspartate transaminase or Alanine aminotransferase >5 × upper limit of normal)；
- •(3) Tumor invade the Inferior Vena Cava, extrahepatic spread;
- •(4) Any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
- •(5) Renal failure,cardiac ejection fraction (<50 %) or end-stage disease;
- •(6) Patients who were not capable of cooperation during the procedure.
研究组 & 干预措施
Endovascular Brachytherapy&Stent&TACE
Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation.
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Stent and Iodine-125 seed strand implantation (Procedure)
Endovascular Brachytherapy&Stent&TACE
Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation.
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Stent (Device)
Endovascular Brachytherapy&Stent&TACE
Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation.
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Iodine-125 seed (Device)
Endovascular Brachytherapy&Stent&TACE
Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation.
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Epirubicin (Drug)
Endovascular Brachytherapy&Stent&TACE
Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation.
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Ultra-fluid lipiodol (Drug)
Endovascular Brachytherapy&Stent&TACE
Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation.
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Gelatin sponge articles (Other)
TACE alone
Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Epirubicin (Drug)
TACE alone
Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Ultra-fluid lipiodol (Drug)
TACE alone
Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
干预措施: Gelatin sponge articles (Other)
结局指标
主要结局
Overall Survival
时间窗: From the date of randomization until the date of death from any cause, assessed up to 24 months
次要结局
- Time To Progression(From the date of first procedure of TACE or combined therapy until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 24 months)