Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 11
- 主要终点
- rwTEAE
研究概览
简要总结
This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pancreatic ductal adenocarcinoma diagnosed by pathology or imaging;
- •Age ≥18 years old, male or female;
- •Patients receiving treatment based on irinotecan hydrochloride liposome injection II;
- •The subjects voluntarily joined the study and signed the informed consent.
排除标准
- •Confirmed pregnant or lactating women;
- •The researchers determined that other conditions were not suitable for inclusion in the study.
研究组 & 干预措施
Perioperative cohort
Irinotecan liposome II combination therapy regimen for perioperative patients
干预措施: Irinotecan liposome II combination therapy regimen (Drug)
结局指标
主要结局
rwTEAE
时间窗: 3 years
real word treatment emergent adverse event
次要结局
- TTP(3 years)
- OS(3 years)
- PFS(3 years)
- DCR(3 years)
- ORR(3 years)