NCT05222204已完成2 期
Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
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
- •Patients should meet the following criteria before treatment to be included in the trial:
- •Voluntarily participate and sign the informed consent;
- •Age ≥18 years old and ≤75 years old, gender is not limited;
- •ECOG score ≤2 points;
- •Pathological diagnosis of pancreatic adenocarcinoma;
- •Advanced pancreatic cancer with intra-abdominal metastasis in imaging assessment, or intra-operative intra-operative findings of intra-abdominal metastasis;
- •The time from the end of adjuvant chemotherapy after surgery is more than 6 months, or they have not received any form of anti-tumor therapy before, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;
- •No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
- •Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
- •Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
- •Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
- •Able to comply with research visit plans and other protocol requirements.
- •inclusion criteria (Cohort B)
- •Patients should meet the following criteria before treatment to be included in the trial:
- •Voluntarily participate and sign the informed consent;
- •Age ≥18 years old and ≤75 years old, gender is not limited;
- •ECOG score ≤2 points;
- •Pathological diagnosis of pancreatic adenocarcinoma;
- •malignant ascites with positive peritoneal cytology or Laparoscopic exploration processed.
- •At least one systemic chemotherapy has been used;
- •No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
- •Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
- •Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
- •Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
- •Able to comply with research visit plans and other protocol requirements.
排除标准
- •Patients were excluded from the study if they met any of the following criteria:
- •Associated with other systemic malignant tumors;
- •Single kidney, deformed kidney or poor renal compensation;
- •Have used any other study drug within 7 days before chemotherapy;
- •Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
- •There is a history of allergy to the study drug or drugs of similar structure;
- •Patients who are using and require long-term use of warfarin anticoagulation.
研究组 & 干预措施
IP
Experimental
intravenous AG+ IP cisplatin
干预措施: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel (Drug)
结局指标
主要结局
overall survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
patients the time from enrollment to death from any cause
次要结局
未报告次要终点
研究者
Xian-Jun Yu
Principal Investigator
Fudan University
研究点 (2)
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