NCT04224402已完成2 期
Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
Yuhong Li1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Regression Free Survival
研究概览
简要总结
This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection.
详细描述
The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be voluntary to the trial and provide with signed informed consent.
- •Histologically confirmed diagnosis of pancreatic cancer
- •Male or female, Age: 18-79 years old.
- •No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery.
- •the value of Carbohydrate Antigen19-9(CA19-9) < 180U/mL within 12 weeks after surgery.
- •No previous chemotherapy
- •Eastern Cooperative Oncology Group(ECOG) performance status of 0-1
- •normal function of organ system including the followings.
- •No hematologic dysfunction(Platelets ≥90×10^9/L; Neutrophil ≥2×109/L;Hemoglobin ≥90g/L).
- •Serum bilirubin ≤ 1.2 × upper limits of normal(ULN); aminotransferase ≤ 5 × ULN.
- •Serum creatinine ≤ 1.25× ULN, or creatinine clearance rate(CCR) ≥60mL/min(calculated by Cockcroft-Gault formula).
- •ECOG scored as 0-
- •Life expectancy > 3 months.
排除标准
- •Patient is concurrently using other antineoplastic agent.
- •Known severe hypersensitivity to drugs in the regimen.
- •Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).
- •Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.
- •Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
- •Evidence of active infection or active epidemic disease.
- •Psychiatric illness that would prevent the patient from giving informed consent
- •Pregnant or lactating women.
研究组 & 干预措施
mFOLFIRINOX
Other
Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion
干预措施: mFOLFORINOX (Drug)
结局指标
主要结局
Regression Free Survival
时间窗: Up to 24 months
defined as the period from the date of resection to tumor relapse caused by any reason
次要结局
- Overall Survival(Up to 24 months)
研究者
Yuhong Li
Clinical Professor
Sun Yat-sen University
研究点 (1)
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