Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- disease-free survival (DFS)
研究概览
简要总结
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. Led by The First Affiliated Hospital with Nanjing Medical University and Peking University Cancer Hospital & Institute (as leading centers), its main purpose is to evaluate the clinical efficacy and safety of Nimotuzumab combined with nab-paclitaxel plus gemcitabine (AG) in the perioperative treatment of high-risk resectable/borderline resectable pancreatic cancer.
详细描述
This clinical study is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled trial, led by two leading centers: The First Affiliated Hospital with Nanjing Medical University and Peking University Cancer Hospital & Institute. Its main purpose is to evaluate the clinical efficacy and safety of Nimotuzumab combined with nab-paclitaxel plus gemcitabine (AG regimen) in the perioperative treatment of high-risk resectable/borderline resectable pancreatic cancer. Approximately 156 patients will be enrolled in this study and randomly assigned in a 1:1 ratio to the experimental group (Nimotuzumab plus AG regimen) and the control group (placebo plus AG regimen). The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), R0 resection rate, preoperative objective response rate (ORR), incidence of postoperative complications, and safety, etc.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •1. Age 18-75 years old, gender unlimited;
- •2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
- •3. Confirmed as resectable/borderline resectable pancreatic cancer by CT/MRI imaging (resectability assessment refers to NCCN guidelines). For resectable pancreatic cancer, at least one of the following high-risk factors must be met: 1) CA199 > 500 U/ml; 2) the maximum diameter of the primary tumor > 3.0 cm; 3) Severe weight loss (BMI < 18.5 kg/m² OR involuntary weight loss > 15% within 6 months); 4) Severe pain (Numeric Rating Scale [NRS]≥ 4); 5) Definite regional lymph node metastasis (N1 or N2) OR suspicious regional lymph node metastasis (short-axis diameter of lymph nodes ≥15 mm);
- •4. Voluntarily agree to sample collection (for KRAS gene testing and post-hoc analysis);
- •5. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥80×10^9/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≤1.5×ULN or estimated creatinine clearance > 60 mL/min;
- •6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2;
- •7. Life expectancy of at least 3 months;
- •8. Women of childbearing age should have a negative result of serum HCG or urine pregnancy tests within 72 hours prior to randomization (Postmenopausal women who have had amenorrhea for at least 12 months are considered sterile and women known to have had tubal ligation are not required to undergo pregnancy tests) ;
- •9. Good compliance and signed informed consent.
排除标准
- •1. Previous treatment for pancreatic cancer.
- •2. Accompanied by other serious diseases, including but not limited to: active infections; unmanageable diabetes mellitus and uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg); compensatory heart failure (NYHA grade III and IV), unstable angina or poorly controlled arrhythmias within 3 months prior to randomization; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; digestive tract obstruction; respiratory insufficiency and severe lung disease; central nervous system disease or mental illness;
- •3. Clinically diagnosed as local recurrence of pancreatic cancer, or there is evidence of peritoneal/other distant metastases;
- •4.History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- •5. Presence of bleeding or coagulation disorders;
- •6. Known allergy to prescription or any component of the prescription used in this study;
- •7. Known HIV infection, syphilis infection, or active hepatitis (hepatitis B or C);
- •8. Women who are pregnant or are breastfeeding;
- •9.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
研究组 & 干预措施
Nimotuzumab+ AG
干预措施: AG regimen (Drug)
Nimotuzumab+ AG
干预措施: Nimotuzumab (Drug)
Placebo+ AG
干预措施: AG regimen (Drug)
Placebo+ AG
干预措施: Placebo (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)
- R0 resection rate(within 30 days after surgery)
- Surgical Resection rate(within 30 days after surgery)
- Objective response rate (ORR)(Up to 9 weeks during the neoadjuvant treatment)
- adverse events(Up to 30 days after last administration)