NCT05074589已完成3 期
A Randomized, Double-blind, Single-dummy, Parallel-controlled, Multicentre, Phase III Clinical Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically or cytologically confirmed pancreatic cancer;
- •Unresectable locally advanced or metastatic disease ;
- •Documented disease progression after first-line treatment gemcitabine based therapy
- •Adequate organ and bone marrow function;
- •sign an informed consent.
排除标准
- •Active CNS metastasis;
- •Uncontrolled tumor-related pain;
- •Clinically significant GI disorders;
- •Significant cardiovascular disease;
- •Active infection or uncontrolled fever;
- •Pregnant or breast feeding patients;
- •Allergic to a drug ingredient or component;
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
Treatment group A
Experimental
Irinotecan liposome plus 5-fluorouracil, Leucovorin
干预措施: Irinotecan liposome、5-Fluorouracil、Leucovorin (Drug)
Treatment group B
Active Comparator
Placebo plus 5-fluorouracil, Leucovorin
干预措施: Placebo、5-Fluorouracil、Leucovorin (Drug)
结局指标
主要结局
Overall Survival(OS)
时间窗: The maximum time in follow up was approximately 12 months
OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.
次要结局
- Progression Free Survival(The maximum time in follow up was 12 months)
- Objective Response Rate(Assessment every 6 weeks after initial response; maximum time on study 12 months)
- Time to Treatment Failure(The maximum time in follow up was 12 months)
- Quality of life（QoL）(Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months)
- Percentage of Patients With Tumor Marker (CA 19-9) Response(Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 12 months)
研究者
研究点 (1)
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