Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection:a Non-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- recurrence-free survival
研究概览
简要总结
This study is a prospective non-randomized controlled study. The purpose of this study is to evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after radical surgery.
详细描述
HCC is the sixth most common malignancy worldwide.Selected patients with HCC are candidates for potentially curative therapy, such as hepatic resection and liver transplantation. Nevertheless,tumor recurrence is 70 % at 5 years after resection and 15-30 % after liver transplantation,leading to tumor-related death.MVI is currently one of the most critical factors predictive of HCC recurrence.There are no approved effective interventional measures to improve the outcome of this patients with MVI.The purpose of this study is to explore the validity and safety of sorafenib and TACE for MVI in HCC patients after radical resection.The candidates will be assigned to sorafenib group (about 30 cases),TACE group (about 30 patients) and control group (about 30 cases)，according to the willingness of the subject.All patients will be followed up for 3 years and Recurrence-free survival and overall survival will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •18-75 years of age;
- •The liver tumor has been radically resected;
- •Postoperative pathology proved to be hepatocellular carcinoma with negative margin and microvascular invasion;
- •Imaging evaluations(CT/MRI) were performed at 1 month after the resection and no area of enhancement was seen;
- •Child-Pugh A;
- •Eastern Cooperative Oncology Group(ECOG) body condition score (PS) 0-1;
- •Then patients understand and voluntarily signed a written informed consent;
排除标准
- •Recurrent HCC;
- •pathology-proved multifocal HCC or HCC with satellite nodules;
- •Tumor thrombus in portal vein or inferior vena cava trunk;
- •Patients with extrahepatic metastasis found by radiologic or pathologic examination;
- •severe dysfunction of the heart, kidney, or other organs.The patients cannot tolerate TACE or sorafenib after general assessment of the situation;
- •Enrolled in other clinical study at the same time;
- •Previously treated with other antitumor treatments except the resection;
- •The researchers believe that the patient does not fit this study;
- •Pregnant or lactating women.
研究组 & 干预措施
sorafenib group
sorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally).
干预措施: Sorafenib (Drug)
TACE group
TACE group patients will accept TACE therapy once at a month after resection.
干预措施: TACE (Procedure)
结局指标
主要结局
recurrence-free survival
时间窗: 36 month
次要结局
- overall survival(36 month)
研究者
Xinyu Bi
Xinyu Bi
Chinese Academy of Medical Sciences