NCT00514228已完成2 期
Continuous Sunitinib Treatment in Patients With Unresectable Hepatocellular Carcinoma A Multicenter Phase II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Sunitinib 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.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Demonstrate the antitumor activity of continuous sunitinib malate treatment in patients with unresectable hepatocellular carcinoma.
Secondary
- Evaluate the safety of sunitinib malate treatment.
- Measure serum cobalamin (i.e., vitamin B12) level during sunitinib malate treatment in order to investigate the relationship between sunitinib malate treatment and cobalamin deficiency.
- Control the cobalamin deficiency by cobalamin replacement.
- Investigate whether changes in tumor density could be used as a criterion for tumor response in future trials.
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 —（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
Continuous sunitinib treatment
Experimental
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Progression-free survival
时间窗: at 12 weeks
次要结局
- Objective response(Objective response (CR+PR) to treatment will be determined. CR or PR is to be confirmed after a minimum of 4 weeks)
- Disease stabilization (DS)(Disease stabilization (CR, PR or SD) under sunitinib treatment will be determined)
- Duration of DS(Duration of DS (CR, PR or SD) will be calculated from the time that measurement criteria are met for the first time until documented tumor progression)
- Progression-free survival(PFS will be calculated from registration until documented tumor progression or death, whichever occurs first.)
- Time to progression(TTP will be calculated from registration until documented tumor progression or death due to tumor.)
- Overall survival(OS will be calculated from registration until death)
- Adverse events as assessed by NCI CTCAE v3.0(All AEs will be assessed according to NCI CTCAE v3.0.)
- Serum alpha fetoprotein level(Serum AFP levels will be measured during the therapy, if AFP is ≥ 1.5 x ULN at baseline.)
研究者
研究点 (1)
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