Clinical Study of Capeline Combined With Gemcitabine in the Treatment of Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation the clinical partial response (PR) at 6 weeks intervals
研究概览
简要总结
Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.
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
Canagliflozin and Gemcitabine
干预措施: Canagliflozin and Gemcitabine (Drug)
standard cisplatin
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Evaluation the clinical partial response (PR) at 6 weeks intervals
时间窗: 18 weeks
the overall reduction in the longest diameter of the tumor focus is \> 50% and it can be maintained for at least 4 weeks, with no new focus emerging
Evaluation the clinical stable disease (SD) at 6 weeks intervals
时间窗: 18 weeks
the overall reduction or increase of the longest diameter of the tumor lesion is \< 50% or \< 25%, and the duration is \> 4 weeks; no new lesion appears
Evaluation the clinical disease progression (PD) at 6 weeks intervals
时间窗: 18 weeks
the combined increase in the longest diameter of the tumor lesion is ≥25%, or a new lesion appears
Evaluation the clinical complete response (CR) at 6 weeks intervals
时间窗: 18 weeks
The tumor lesion in our patient completely resolved and lasted for ≥4 weeks, and no new lesion appeared
次要结局
未报告次要终点
研究者
Zhang Xiaofeng,MD
chief physician
First People's Hospital of Hangzhou