NCT06688240尚未招募不适用
A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)
Servier (Tianjin) Pharmaceutical Co. LTD.0 个研究点目标入组 120 人开始时间: 2024年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
研究概览
简要总结
The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland.
Primary objective
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
- Quantify the rate of grade ≥3 neutropenia (primary objective)
- Serious adverse events and serious adverse drug reactions
- Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment
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
- •The adult patient (≥18 years of age) has given written informed consent to participate in the study.
- •The patient has been prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC.
- •Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas.
- •Documented metastatic disease.
- •Patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy.
排除标准
- •Patients who have experienced a severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL.
- •Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease.
- •Pregnant or nursing (lactating) women.
- •Patients without highly effective methods of contraception during study treatment until 3 months after the last dose of the study drug, Specially,7 months for women of childbearing potential and 4 months for male with partners of childbearing potential after the last dose of the study drug.
- •Other additional exclusions may be applied by the investigator according to the contexts, in order to ensure that the study population will be non-interventional but representative of all eligible subjects.
结局指标
主要结局
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
时间窗: From enrolment until 30 days after last ONIVYDE administration
(3) Adverse events and adverse drug reactions
次要结局
- To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.(From FPI to 12 months after LPI)
研究者
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