Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- progression free survival and overall survival
研究概览
简要总结
Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological or cytological confirmed advanced hepatocellular carcinoma
- •18 years to 80 years
- •liver function Child-Pugh class B
- •BCLC stage B or C
- •estimated life time 2 months or longer
排除标准
- •previous target therapy
- •allergy to Sorafenib
- •Uncontrolled Bleeding or diarrhea
- •eligible for locoregional treatment
研究组 & 干预措施
sorafenib
sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.
干预措施: Sorafenib (Drug)
sorafenib
sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.
干预措施: Best Supportive Care (Other)
Best Supportive Care
treatment mainly on nutrition and symptoms control
干预措施: Best Supportive Care (Other)
结局指标
主要结局
progression free survival and overall survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause up to 12 months
次要结局
- response rate(every 4 weeks till progression, total up to 12 months)
研究者
Youxin Ji
Chief, Department of Oncology
Qingdao Central Hospital