A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study is designed to evaluate the real world efficacy and safety of the liposomal irinotecan (Onivyde®)-based treatment scheme in Chinese patients with locally advanced or metastatic pancreatic cancer, and to compare the efficacy with that of the whole pancreatic cancer population who did not receive relevant treatment.
详细描述
Chinese patients with pancreatic cancer are mostly treated according to foreign clinical research, lacking the diagnosis and treatment data of efficacy and safety of Chinese population. In the NAPOLI-1 study, irinotecan liposomes (Onivyde®) The combination of 5-fluorouracil and folinic acid (Nal-IRI+5-FU/LV) has shown survival benefits in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have previously received gemcitabine-based treatment. The NAPOLI-3 study showed that NALIRIFOX (Nal-IRI+oxaliplatin+5-FU/LV) significantly improved overall survival (OS) and progression free survival (PFS) compared to albumin bound paclitaxel and gemcitabine in newly diagnosed mPDAC patients. However, the efficacy and safety data of Nal-IRI-based treatment regimens in China are limited. In August 2023, Onivyde® was commercially listed in China. The purpose of this study is to: ① evaluate the real world efficacy and safety of Onivyde®-based treatment schemes in Chinese patients with locally advanced or metastatic pancreatic cancer; ② analyze the efficacy of Onivyde® treatment and the efficacy of all pancreatic cancer patients who have not received relevant treatment using the project data of China Advanced pancreatic cancer Big Data Center (Renji Hospital Cancer Department is the national leading unit), in conjunction with the survival follow-up data of China Center for Disease Control and Prevention of Chronic Non communicable Diseases.
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 —（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
- •Confirm pregnant or lactating women.
- •The patient's clinical data is not available.
- •The researchers determined that they were not suitable for inclusion in the study due to other circumstances.
研究组 & 干预措施
Experimental group
Liposomal irinotecan (Onivyde®)-based treatment.
干预措施: Nal-IRI (Onivyde®)-based treatment (Drug)
Control group
Real medication data from accepting other second-line treatment options in the China Pancreas Data Center (CPDC) project.
干预措施: Other second-line treatment (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 24 months
Overall Survival (OS) is defined as the time from enrollment to death from any cause.
次要结局
- Progression-Free Survival (PFS)(Up to 24 months)
- Time To Progress (TTP)(Up to 24 months)
- Overall Response Rate (ORR)(Up to 24 months)
- Disease Control Rate (DCR)(Up to 24 months)
- Safety and tolerability by incidence, severity and outcome of adverse events(Until 30 day safety follow-up visit)