NCT04913662Unknown1 期
Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Recommended dose
研究概览
简要总结
This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed as gastric adenocarcinoma
- •Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
- •HER-2 negative tumor
- •Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)
- •Absolute Neutrophil Count: ≧ 1,500/mm³
- •Hemoglobin level: ≧ 8.0g/dL
- •Platelet Count: ≧ 10×104/mm³
- •AST (GOT), ALT (GPT): ≦ 100U/L
- •Total Bilirubin: ≦ 2.0mg/dL
- •Creatinine Clearance (CCl): ≧ 50mL/min
- •ECOG 0 - 2
排除标准
- •Patients with other major medical disease or malignant tumors other than gastric cancer
- •Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
- •Pregnant, breast-feeding women or with birth plan
- •History of gastrointestinal surgery
- •Patients refusing treatment
结局指标
主要结局
Recommended dose
时间窗: Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)
Recommended dose of paclitaxel for a phase II trial
次要结局
未报告次要终点
研究者
Hyung-Ho Kim
Professor
Seoul National University Bundang Hospital
研究点 (2)
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