Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Macrovascular invasion (MVI) is common in HCC, Portal vein tumor thrombus (PVTT) is the most common form of MVI in HCC, with an incidence ranging from 44 to 62.2%. About 10% to 60% of HCC patients have PVTT at the time of diagnosis. the prognosis for those with PVTT remains poor, as their median survival is only 2-4 months via supportive care. There is currently no widely-accepted consensus for the management of HCC with PVTT. According to some guidelines in Europe and America, HCC with PVTT is regarded as Stage C per Barcelona Clinic Liver Cancer (BCLC) Staging system, and sorafenib alone is recommended as the treatment of choice. This study is to analyze the safety and efficacy of radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or TACE;
- •an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2;
- •no refractory ascites;
- •Child-Pugh class A and B, or class C with good performance status;
- •no previous radiotherapy to the liver;
- •more than 700 cc of uninvolved liver
排除标准
- •Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
- •Diffuse HCC or accompanied by distant metastasis;
- •Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
- •Patients with a history of hepatic encephalopathy
结局指标
主要结局
overall survival
时间窗: from enrollment to death (for any reason).assessed up to 12 months
The time from the patient received treatment to died from any cause
次要结局
- objective response rate(from enrollment to progression or death (for any reason),assessed up to 12 months)