Phase 2 Study of Sequential Hyperthermic Intraperitoneal Chemotherapy of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis or Positive Free Cancer Cells in Abdomen
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proved gastric adenocarcinoma.
- •Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid.
- •Potentially resectable gastric cancer.
- •ALT, AST < 80U/L; Total Bilirubin < 30μmol/L; WBC > 4x10^9/L; PLT > 100x10^9/L; Cr < 1.5 fold normal value.
- •ECOG 0-2 points.
- •Expected survival time longer than 3 months.
- •Informed consent.
排除标准
- •Recurrent gastric cancer.
- •Pregnant or lactating women.
- •Allergic to oxaliplatin or paclitaxel.
- •Abnormal liver/kidney function.
- •Serious heart/metabolic disease.
研究组 & 干预措施
HIPEC
干预措施: Oxaliplatin (Drug)
HIPEC
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Survival
时间窗: every 3 month postoperation up to 24 months
次要结局
- Safety(every 3 month postoperation up to 24 months)
研究者
Jiafu Ji
Director
Peking University