Gemcitabine Plus S-1 as the First-line Chemotherapy in Chinese Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Gemcitabine plus S-1 (GS) prolonged progression-free survival (PFS) and greatly improved objective response rate (ORR) as well as disease control rate (DCR) of Asian patients with locally advanced and metastatic pancreatic cancer (PC). However, limited data of GS regimen exist on the efficacy and safety in the treatment of Chinese patients with advanced PC. To assess the efficacy and safety of gemcitabine plus S-1 (GS regimen) as the first-line chemotherapy in Chinese patients with advanced PC, we designed this prospective study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Histologically confirmed pancreatic adenocarcinoma 2.Locally advanced or metastatic PC 3.Chemotherapy-naïve 4.ECOG performance status of 0 or 1
- •An adequate bone marrow, liver function and kidney function
排除标准
- •1.Age ≥80 years 2.Brain metastasis 3.With other malignancies 4.Chronic diarrhea, cardiac disease, pregnancy or breast feeding
研究组 & 干预措施
LAPC or MPC patients with GS first-line chemotherapy
干预措施: GS (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2014-01-01 to 2017-12-31
the time from the beginning of chemotherapy to the date of disease progression or death from any cause.
Overall survival
时间窗: 2014-01-01 to 2017-12-31
the time from the beginning of chemotherapy to the date of death from any cause.
次要结局
- Objective response rate(2014-01-01 to 2017-12-31)
- adverse events(2014-01-01 to 2017-12-31)
研究者
Weijia Fang, MD
director
Zhejiang University