Peritoneal Perfusion Chemotherapy Combined With Gemcitabine and Albumin Binding Paclitaxel Versus Gemcitabine and Albumin Binding Paclitaxel in the Treatment of Advanced Pancreatic Cancer With Intraperitoneal Metastasis
试验速览
- 阶段
- 1 期
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Ascites control
研究概览
简要总结
In view of the existence of malignant ascites in patients with advanced pancreatic cancer, we put forward the heat abdominal cavity perfusion chemotherapy combined albumin paclitaxel and gemcitabine compared with albumin paclitaxel and gemcitabine prospective clinical study, to assess abdominal albumin hot perfusion chemotherapy combined control of ascites and taxol in improving patients' quality of life, survival, exploring the feasibility of celiac hot perfusion chemotherapy combined albumin paclitaxel and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participate voluntarily and sign informed consent;
- •Age ≥18 years old and ≤80 years old, regardless of gender;
- •Physical condition ECOG 0 ~ 2;
- •The diagnosis of pancreatic adenocarcinoma was confirmed by pathology;
- •Peritoneal metastasis was confirmed by ascites cytology, or was pathologically confirmed by surgical exploration and biopsy;
- •Expected survival ≥3 months;
- •No serious abnormal blood system, heart and lung function and immune deficiency (refer to respective standards);
- •Blood routine indicators: white blood cell (WBC) ≥3 × 109/L;Absolute count of neutrophils (ANC) ≥1.5 × 109/L;Platelet (PLT) ≥100 × 109/L;Hemoglobin (Hgb) ≥9 g/dL;
- •Blood biochemical indexes: AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of normal value (ULN);Total bilirubin (TBIL) ≤ULN;Serum creatinine (CRE) ≤1.5 × ULN;
- •Coagulation function: Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN;
- •Comply with the study visit plan and other program requirements.
排除标准
- •Accompanied by other systemic malignant tumors;
- •Received any form of anti-tumor therapy, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, tumor palliative resection and molecular targeted therapy;
- •Used any other study drugs within 5 weeks before enrollment;
- •Central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
- •Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) has not been corrected.
- •A history of allergy to study drugs or similar structured drugs;
- •Pregnant or lactating women;
- •Any conditions, including serious medical risk factors, medical conditions, and laboratory abnormalities, that may impair patient safety or the integrity of research data;
- •Intestinal obstruction, extensive adhesion in the peritoneal cavity, abdominal inflammation, etc.
研究组 & 干预措施
Thermal perfusion cisplatin+Nab-paclitaxel+GEM
Laparoscopic exploration + thermal perfusion cisplatin 40 mg/m2, Postoperative exploration D1, 8 Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 after the second thermal perfusion 4 weeks plan, 6 cycles
干预措施: cisplatin+Nab-paclitaxel+GEM (Drug)
Nab-paclitaxel+GEM
Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 4 weeks plan, 6 cycles
干预措施: Nab-paclitaxel+GEM (Drug)
结局指标
主要结局
Ascites control
时间窗: 4 weeks
The change of abdominal volume of subjects from enrollment.
次要结局
未报告次要终点
研究者
Xian-Jun Yu
President of Shanghai Pancreatic Cancer Institute
Fudan University