Multicenter Phase II Study of Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma With Major Portal Vein Invasion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 16
- 主要终点
- Tumor stabilization rate
研究概览
简要总结
Recently, several studies reported promising outcomes of patients after external beam radiotherapy (EBRT) for hepatocellular carcinoma (HCC) with portal vein tumor thrombosis. However, conventional EBRT is composed of many fractions (20-35 fractions). On the other hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a high dose of radiation to the target using a few fractions with a high precision within body. SABR increases radiation biologic effect for tumor, makes patients more comfortable due to reduction of the number of hospital visit, and enables patients to receive another treatment more quickly. This study will evaluate SABR effect with 40 Gy in 4 fractions for HCC with major 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 20 years of age
- •Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •HCC with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein)
- •Cirrhotic status of Child Pugh class A or B7
- •Patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months.
- •Patient or guardian must be able to provide verbal and written informed consent
排除标准
- •Prior trans-arterial chemo-embolization ≥4 after diagnosis of major portal vein tumor thrombosis
- •Severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy)
- •Uncontrolled inter-current illness except liver cirrhosis
结局指标
主要结局
Tumor stabilization rate
时间窗: 2 months
Tumor stabilization rate was based on the combined number of patients with complete response(CR), partial response(PR), and stable disease(SD) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
次要结局
- Overall survival(6 months, 1 year and 2 year)
- Tumor progression free survival(6 months, 1 year and 2 year)
- Treatment related toxicity(1 year)
研究者
Mi-Sook Kim
Doctor
Korea Cancer Center Hospital