Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.
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 —（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
Gimatecan group
All patients will receive gimatecan (0.8mg/m2, on days 1 to 5, PO, every 4 weeks) until progressive disease (PD).
干预措施: Gimatecan (Drug)
placebo group
All patients will receive tegafur, gimeracil and oteracil potassium (40-60mg, twice daily, on days 1 to 14 , PO, every 3 weeks) or gemcitabine (1000mg/m2, on days 1、8, IV, every 3 weeks) until progressive disease (PD).
干预措施: tegafur, gimeracil and oteracil potassium (Drug)
placebo group
All patients will receive tegafur, gimeracil and oteracil potassium (40-60mg, twice daily, on days 1 to 14 , PO, every 3 weeks) or gemcitabine (1000mg/m2, on days 1、8, IV, every 3 weeks) until progressive disease (PD).
干预措施: gemcitabine (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
The 2-year progression free survival of the whole group.
次要结局
- Overall survival (OS)(From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.)
- Objective response rate (ORR)(To evaluate objective response rate every 6 weeks after the initiation of chemotherapy, up to 24 months.)
- Duration of Response (DoR)(First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months.)
- Disease control rate (DCR)(To evaluate disease control rate every 6 weeks after the initiation of chemotherapy, up to 24 months.)
- Patient-reported outcome (PRO)(To evaluate every 6 weeks after the initiation of chemotherapy, up to 24 months.)