A Prospective, Single Arm Study of Nimotuzumab Combined With Gemcitabine and Nab-paclitaxel as Conversion Therapy in Pancreatic Cancer With Liver Metastasis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.
详细描述
This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (gemcitabine and nab-paclitaxel) in the treatment of pancreatic cancer with liver metastasis. Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy. The resectability of the primary pancreatic lesion and liver metastases will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts. The main endpoint is R0 resection rate. Additional end points included resection rates, overall survival (OS), objective response rate (ORR), safety, etc.
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
- •Age 18-75 years old, gender unlimited;
- •Histologically or cytologically confirmed pancreatic cancer with liver metastasis;
- •Pancreatic cancer with liver metastasis, which is considered to be potentially resectable judged by a multidisciplinary team;
- •Receive nimotuzumab-based conversion therapy for voluntary;
- •No prior tumor systemic therapy;
- •Measurable disease according to RECIST criteria v1.1;
- •Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥100×10^9/L; serum total bilirubin (TBIL)≤3×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 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;
- •Life expectancy is expected to be ≥3 months;
- •Fertile subjects are willing to take contraceptive measures during the study period.
- •Good compliance and signed informed consent voluntarily.
排除标准
- •Refuse chemotherapy or surgery;
- •Other part (e.g. peritoneum, lung, bone, brain) metastasis;
- •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;
- •Undergone major surgery within 30 days;
- •Use of EGFR-mab or EGFR-TKI within 30 days;
- •Known allergy to prescription or any component of the prescription used in this study;
- •With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
- •Grade 2 or above toxicity from prior treatment that has not resolved (excluding anemia, alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity)
- •10.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
Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy.
干预措施: Nimotuzumab (Drug)
Nimotuzumab+AG
Patients will receive Nimotuzumab plus AG as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) will be performed every two cycles (every two months) of conversion therapy.
干预措施: AG (Drug)
结局指标
主要结局
R0 resection rate
时间窗: Up to 6 months
The Proportion of patients who achieved R0 resection (incisal edge\>1cm)
次要结局
- resection rate(Up to 18 months)
- tumor-related markers(Up to 18 months)
- overall survival (OS)(Up to 18 months)
- adverse events(Up to 30 days after last administration)
- Objective response rate (ORR)(Up to 18 months)