Multicenter Retrospective Analysis for Efficacy and Safety of Second-Line Nab-Paclitaxel Plus Gemcitabine After Progression on 1st-line FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
In this study, clinical data of patients who received 2nd-line Nab-paclitaxel plus Gemcitabine (nab-P+GEM) after progression on 1st-line FOLFIRINOX will be reviewed retrospectively.
详细描述
FOLFIRINOX is one of standard 1 st-line regimens for patients with advanced PDAC. However, there is no globally established 2 nd-line regimen after the failure of FOLFIRINOX. Although gemcitabine-based regimens are recommended by multiple guidelines and widely used in daily practice, further analysis is needed to reveal the magnitude of clinical benefit with these regimens. Nab-paclitaxel plus Gemcitabine (Nab-P+Gem) is another standard 1 st-line regimen for PDAC, but there are limited data as 2 nd-line therapy in PDAC. Therefore, the investigators are conducting a multicenter retrospective analysis of 2 nd-line nab-P+Gem after progression on FOLFIRINOX in patients with advanced PDAC.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed pancreatic ductal adenocarcinoma
- •Administration of 2nd-line nab-paclitaxel plus gemcitabine
- •Progression on 1st-line FOLFIRINOX
排除标准
- •Pathologic diagnosis other than pancreatic ductal adenocarcinoma
- •Administration of nab-paclitaxel plus gemcitabine as 3rd or greater lines of therapy
研究组 & 干预措施
nab-P + GEM
Nab-paclitaxel plus gemcitabine
干预措施: nab paclitaxel plus gemcitabine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 1 year
Time from the start of 2nd-line nab-P + GEM to disease progression or death from any cause, whichever came first
次要结局
- Overall survival(1 year)
- Objective response rates(1 year)
- Toxicity profile(1 year)
研究者
Changhoon Yoo
Assistant professor
Asan Medical Center