NCT00191971已完成2 期
A Phase II Study of Gemcitabine in Transitional Cell Carcinoma of the Urothelium
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- Response rate
研究概览
简要总结
To investigate efficacy and safety of 2nd line GEM monotherapy after CDDP regimen for patients with transitional cell carcinoma of urothelium
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or cytologically confirmed TCC
- •Received 1st line chemotherapy for locally advanced or metastatic TCC with CDDP regimen
- •To have at least one measurable region
- •To have adequate organ function (bone marrow, liver and renal function)
排除标准
- •To have Interstitial pneumonia or pulmonary fibrosis
- •Within 4 weeks after the latest chemotherapy or radiotherapy
- •To have brain metastasis with symptom
- •To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
结局指标
主要结局
Response rate
次要结局
- Progression-free survival
- Overall survival
研究者
研究点 (12)
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