Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- disease-free survival (DFS)
研究概览
简要总结
This is a prospective, multicenter, single-arm, open-label study. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX/GX for postoperative adjuvant treatment of pancreatic cancer.
详细描述
This clinical study is designed as a prospective, multicenter, single arm, open-label study to evaluate the clinical efficacy and safety of combination Nimotuzumab with mFOLFIRINOX/GX as postoperative adjuvant therapy in pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included overall survival (OS) and safety.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older, gender unlimited;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Had undergone complete macroscopic resection for pancreatic cancer (R0 or R1 resection) with histological confirmation and with no evidence of distant metastasis as demonstrated by imaging;
- •No prior tumor therapy;
- •Adequate organ and bone marrow function, defined as follows: White blood cells (WBC) ≥ 3.0×10^9/L; absolute neutrophil count (ANC)≥1.5×10^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1×ULN or estimated creatinine clearance ≥ 50 mL/min;
- •Left ventricular ejection fraction (LVEF) ≥ 50%;
- •Fertile subjects are willing to take contraceptive measures during the study period.
- •good compliance and signed informed consent voluntarily
排除标准
- •Prior systemic anti-tumor therapy, such as chemotherapy, radiotherapy;
- •Participated in other drug clinical trials within 4 weeks;
- •History of other malignancies;
- •Immunodeficiency, or other immune-related disorders requiring medical intervention;
- •Postoperative complications such as bleeding;
- •Woman who are pregnant or breastfeeding;
- •Drug abuse, or clinical, psychological or social factors that may have an impact on informed consent or the implementation of the study;
- •8.Known allergy to prescription or any component of the prescription used in this study, including nimotuzumab, oxaliplatin, irinotecan, fluorouracil, gemcitabine, and capecitabine.
研究组 & 干预措施
Nimotuzumab+ mFOLFIRINOX/GX
Patients will receive chemotherapy (either mFOLFIRINOX or GX) plus Nimotuzumab as postoperative adjuvant therapy.
干预措施: Nimotuzumab (Drug)
Nimotuzumab+ mFOLFIRINOX/GX
Patients will receive chemotherapy (either mFOLFIRINOX or GX) plus Nimotuzumab as postoperative adjuvant therapy.
干预措施: mFOLFIRINOX (Drug)
Nimotuzumab+ mFOLFIRINOX/GX
Patients will receive chemotherapy (either mFOLFIRINOX or GX) plus Nimotuzumab as postoperative adjuvant therapy.
干预措施: GX (Drug)
结局指标
主要结局
disease-free survival (DFS)
时间窗: Up to 24 months
The time from the date of surgery to the disease recurrence or death, whichever is earlier.
次要结局
- overall survival (OS)(Up to 24 months)
- adverse events(Up to 30 days after last administration)