Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Liver Metastases From Gastrointestinal Tumors and Pancreatic Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants with Serious and Non-Serious Adverse Events
研究概览
简要总结
Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
详细描述
Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.
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Main purpose
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To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
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To explore the largest mechanical index and ultrasonic treatment time which patients can endure.
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Secondary purpose
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To observe tumor clinical benefit rate (CR+PR+SD).
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To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)
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
- •Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
- •Failed routine chemotherapy
- •Neoplasms can be evaluated by imaging
排除标准
- •Have systematic chemotherapy in 2 weeks
- •Be allergic to ultrasonic microbubbles and chemotherapeutics
- •Uncontrolled high blood pressure, cardiovascular disease
- •Active bleeding
- •Have serious mental and psychological disease
研究组 & 干预措施
microbubbles & platinum and gemcitabine
In 30min after chemotherapy, inject ultrasonic microbubbles 1 ml once and inject 5 times in 20min and locate the ultrasonic probe on the lesion The chemotherapy of pancreatic is gemcitabine.The chemotherapy of liver metastases is oxaliplatin with taxol.
干预措施: ultrasonic microbubbles (Device)
microbubbles & platinum and gemcitabine
In 30min after chemotherapy, inject ultrasonic microbubbles 1 ml once and inject 5 times in 20min and locate the ultrasonic probe on the lesion The chemotherapy of pancreatic is gemcitabine.The chemotherapy of liver metastases is oxaliplatin with taxol.
干预措施: platinum and gemcitabine (Drug)
结局指标
主要结局
Number of Participants with Serious and Non-Serious Adverse Events
时间窗: 1 month
次要结局
- Time to Disease Progression(one year)
研究者
Kun Yan
chief director
Peking University Cancer Hospital & Institute