NCT07238283招募中3 期
Irinotecan Hydrochloride Liposome Injection (II) in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 662
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Irinotecan Hydrochloride Liposome Injection (II) combined with oxaliplatin and 5-FU/LV versus nab-paclitaxel combined with gemcitabine as first-line treatment for advanced pancreatic cancer.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status 0 or 1
- •Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease.
- •Life expectancy of greater than or equal to3 months.
- •At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
- •Able and willing to provide a written informed consent
排除标准
- •Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
- •Known history of central nervous system (CNS) metastases.
- •Severe infection (> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
- •Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
研究组 & 干预措施
Treatment group A
Experimental
Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
干预措施: Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate (Drug)
Treatment group B
Active Comparator
nab-paclitaxel in combination with gemcitabine
干预措施: nab-paclitaxel; gemcitabine (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: From study start until target OS events have occurred (approximately 18 months after last patient enrollment)
次要结局
- Objective Response rate (ORR)(up to 6 months following the date the last patient was randomized)
- Disease Control Rate(up to 6 months following the date the last patient was randomized)
- Duration of Response(up to 6 months following the date the last patient was randomized)
- Progression free survival (PFS)(From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first,assessed up to 18 months)
研究者
研究点 (1)
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