Sorafenib Alone Versus Sorafenib Combined With Hepatic Arterial Chemoinfusion for Advanced HCC With Portal Vein Tumor Thrombosis: a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 247
- 试验地点
- 5
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).
详细描述
The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to find out it.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- •Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
- •portal vein tumor thrumbus confirmed in two image techniques
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •with no previous treatment
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only
- •Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- •The following laboratory parameters:
- •Platelet count ≥ 75,000/µL
- •Hemoglobin ≥ 8.5 g/dL
- •Total bilirubin ≤ 30mmol/L
- •Serum albumin ≥ 30 g/L
- •ASL and AST ≤ 5 x upper limit of normal
- •Serum creatinine ≤ 1.5 x upper limit of normal
- •INR ≤ 1.5 or PT/APTT within normal limits
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Ability to understand the protocol and to agree to and sign a written informed consent document
排除标准
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •Known history of HIV
- •History of organ allograft
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Evidence of bleeding diathesis.
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •Known central nervous system tumors including metastatic brain disease
研究组 & 干预措施
Sorafenib combined with HAIC
Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
干预措施: Sorafenib (Drug)
Sorafenib combined with HAIC
Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
干预措施: Hepatic arterial infusion chemotherapy (Procedure)
Sorafenib combined with HAIC
Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
干预措施: Folfox Protocol (Drug)
Sorafenib alone
Sorafenib alone
干预措施: Sorafenib (Drug)
结局指标
主要结局
Overall survival
时间窗: 6 months
Overall survival
次要结局
- Time to progression(6 months)
- Number of of Patients developed Adverse Events(30 days)
- Adverse Events(30 days)
研究者
Shi Ming
professor
Sun Yat-sen University