NCT06722911招募中2 期
Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.
详细描述
This clinical study is designed as a prospective, open-label, single arm, phase II study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (nab-paclitaxel+ gemcitabine) as postoperative adjuvant therapy in patients with EGFR-positive pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent.
- •Age 18-75 years old, gender unlimited;
- •Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;
- •Postoperative pathology suggested R0/R1 resection;
- •EGFR positive (by immunohistochemistry);
- •KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);
- •Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥80×10^9/L; hemoglobin≥9.0 g/dL; 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;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Postoperative survival is expected to be ≥3 months;
- •Fertile subjects are willing to take contraceptive measures during the study period.
排除标准
- •Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;
- •History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- •Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
- •Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;
- •CA199>180 U/ml within 21d before adjuvant therapy;
- •Known allergy to prescription or any component of the prescription used in this study;
- •Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
- •8 .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
Experimental
干预措施: Nimotuzumab (Drug)
Nimotuzumab+ AG
Experimental
干预措施: AG (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
- distant metastasis-free survival (DMFS)(Up to 24 months)
- overall survival (OS)(Up to 24 months)
- tumor-related markers(Up to 24 months)
- adverse events(Up to 30 days after last administration)
研究者
研究点 (1)
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