Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 主要终点
- Progression Free Survival
研究概览
简要总结
The aim of this study was to determine the efficacy and safety of apatinib combined with S-1 on advanced pancreatic cancer patients after failure of first-line chemotherapy.
详细描述
- To observe the curative efficacy of apatinib and S-1 on patients by analyzing the data of overall survival (OS), complete remission (CR) or partial remission (PR), the rate of progression free survival (PFS), levels of CA19-9 and VEGFR in serum [Time Frame: Evaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year].
- To observe any adverse events, including abnormal clinical symptoms and vital signs, abnormal laboratory examinations, and to record the clinical features, severity, occurrence time, duration, management and prognosis of all subjects during the clinical study, and to determine the correlation between these adverse events and the experimental drugs. . The safety of drugs used in advanced pancreatic cancer was evaluated by CTCAE v4.0
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（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
single-arm
Apatinib and S-1 Patients will be offered with Apatinib (500mg/d) and S-1 (60mg/d for BSA<1.25m2, 80mg/d for 1.25<BSA<1.5m2, and 100mg for BSA >1.5m2) until their disease have progressed.
干预措施: Apatinib (Drug)
single-arm
Apatinib and S-1 Patients will be offered with Apatinib (500mg/d) and S-1 (60mg/d for BSA<1.25m2, 80mg/d for 1.25<BSA<1.5m2, and 100mg for BSA >1.5m2) until their disease have progressed.
干预措施: S-1 (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: one year.
Progression-free survival is defined as the time from registration to the earlier of death or disease progression.
次要结局
- Overall Survival(one year.)
- Duration of response(one year.)
- Objective response rate(one year.)
- Disease Control Rate(one year.)
研究者
Kequn Xu
Director, head of oncology department, principal investigator, clinical professor
Changzhou No.2 People's Hospital