Efficacy and Safety of Irinotecan Liposome Injection Combined With Oxaliplatin and Tegafur (NASOX) in Adjuvant Chemotherapy for Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Disease Free Survival, DFS
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
- •ECOG performance status 0 or
- •Life expectancy of greater than or equal to 6 months.
- •Able and willing to provide a written informed consent.
排除标准
- •Patients who cannot eat orally and have gastric emptying disorder after surgery;
- •Patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; Or diarrhea that limits activities of daily living;
- •Patients who cannot eat orally and have gastric emptying disorder after surgery;
- •Patients who cannot eat orally and have gastric emptying disorder after surgery;
研究组 & 干预措施
Irinotecan liposome injection+ Oxaliplatin +Tegafur
Oxaliplatin: 60mg/m2, d1, ivgtt, 2h; Repeat every 15 days; Irinotecan liposomes: 50mg/m2, d1, ivgtt, 90min; Repeat every 15 days; Tegafur: 40-60mg, BID, po, d1-d10, repeat every 15 days; 30 days as one cycle, 6 treatment cycles.
干预措施: Irinotecan liposome injection (Drug)
结局指标
主要结局
Disease Free Survival, DFS
时间窗: baseline up to approximately 21.6 months.
the time from the start of randomization (or the start of treatment in a one-arm trial) to the recurrence of disease or death from any cause, whichever occurs first.
次要结局
- Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE(baseline up to approximately 7 months.)
- Overall Survival, OS(baseline up to approximately55 months.)
- Quality of life, QOL(baseline up to approximately 55 months.)
- The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy(baseline up to approximately 7 months.)
- he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance(baseline up to approximately 7 months.)
研究者
Kuirong Jiang
archiater
The First Affiliated Hospital with Nanjing Medical University