Phase II Trial of Intrahepatic Artery Chemotherapy With Nexavar in Hepatocellular Carcinoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Subjects Experiencing Adverse Events
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing chemotherapy directly into the liver and giving it together with sorafenib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or carboplatin directly into the liver and giving it together with sorafenib in treating patients with liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To assess the safety of intrahepatic arterial infusion of cisplatin or carboplatin in combination with sorafenib tosylate in patients with unresectable hepatocellular carcinoma.
Secondary
- To assess the time to tumor progression in patients treated with this regimen.
- To assess the overall and progression-free survival of patients treated with this regimen.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cisplatin or Carboplatin + Sorafenib
干预措施: Carboplatin (Drug)
Cisplatin or Carboplatin + Sorafenib
干预措施: Cisplatin (Drug)
Cisplatin or Carboplatin + Sorafenib
干预措施: Sorafenib (Drug)
结局指标
主要结局
Number of Subjects Experiencing Adverse Events
时间窗: 36 months
The number of subjects experiencing adverse events after receiving protocol therapy.
次要结局
- Number of Patients Achieving Clinical Benefit(36 months)