A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
研究概览
简要总结
To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of biliary tract cancer
- •Measurable disease must be at least one lesion
- •Chemotherapy-naïve
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Estimated life expectancy no less than 3 months
排除标准
- •radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia
研究组 & 干预措施
Gemcitabine + Cisplatin
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
干预措施: gemcitabine (Drug)
Gemcitabine + Cisplatin
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
干预措施: cisplatin (Drug)
Gemcitabine
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
干预措施: gemcitabine (Drug)
结局指标
主要结局
Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
时间窗: 1 year
Percentage of patients alive at 1 year.
次要结局
- Tumor Response(baseline to measured progressive disease (up to 2 years))
- Progression Free Survival(baseline to measured progressive disease (up to 2 years))