NCT06155136进行中（未招募）不适用
Real-world Evidence on Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)
Servier Affaires Médicales1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2023年10月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Disease characteristic according to age
研究概览
简要总结
The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI
详细描述
The objectives on patients still alive one year after the first cycle of nal-IRI :
- Characterize mPDAC patient population according to their demographics
- Identify PDAC treatment by line of treatment from diagnosis to last treatment
- Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥ 18 years (≥ 19 years in South Korea)
- •Cytologically confirmed mPDAC at initiation of the nal-IRI treatment
- •All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
- •Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
- •At least one cycle of nal-IRI-containing regimen should have been administered
- •A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen)
- •Availability of data related to survival outcomes in the patient medical record
- •Patients deceased or not at the time of enrollment will be eligible for inclusion in the study
排除标准
- •No documentation of systemic therapy outcomes or prior treatments in patient medical records
- •Patients with second concomitant metastatic malignancy
结局指标
主要结局
Disease characteristic according to age
时间窗: Through study completion (approximatively 5 months)
Tumor stage (localized/locally advanced/metastatic)
次要结局
未报告次要终点
研究者
研究点 (1)
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