NCT02549911Unknown2 期
Hyperthermic Intraperitoneal Chemotherapy, Intravenous Chemotherapy Combined With Surgery for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- R0 resection
研究概览
简要总结
Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.
详细描述
To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis,so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.
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
- •gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.
- •Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
- •Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
- •ECOG (Eastern Cooperative Oncology Group) : 0~2
- •Age: 18~75 years old
- •Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
- •Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
- •Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
- •Not participating in other study projects before and during the treatment
- •Signed the Informed Consent Form
排除标准
- •Not conforming to above inclusion criteria
- •Distal metastasis to lung, liver, or para aortic lymph node metastasis
- •Ever operation on the stomach
- •Operation intolerance due to other systemic basic diseases
- •Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
- •Allergy to the drugs in this protocol
- •Pregnant or lactating women
- •Women at childbearing age and of pregnancy desire during the study
结局指标
主要结局
R0 resection
时间窗: 3 months
the rate of R0 resection
次要结局
- Adverse Events(6 months)
- Overall survival time(3 years)
研究者
研究点 (1)
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