NCT05751850招募中3 期
HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Advanced Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 778
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of this study is to look at the efficacy and safety of HR070803 in combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic 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
HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Experimental
干预措施: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate (Drug)
nab-paclitaxel; gemcitabine
Active Comparator
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 399 OS events have occurred (approximately 15 months after last patient enrollment)
次要结局
- Progression free survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- 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)
研究者
研究点 (1)
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