JPRN-UMIN000008292已完成2 期
A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression - A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine0 个研究点目标入组 20 人开始时间: 2012年6月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. HER2 IHC- or IHC1+, or IHC2+/FISH- 2. Ejection fraction on echo cardiogram<=50% 3. Discontinuation of trastuzumab in first-line chemotherapy due to adverse reaction of trastuzumab 4. Intestinal paralysis or ileus 5. Uncontrolled diarrhea 6. Massive ascites or pleural effusion 7. Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema 8. Uncontrolled diabetes 9. Uncontrolled hypertension 10. Unstable angina pectoris, or a history of myocardial infarction within six months 11. Synchronous cancers 12. Systemic infection requiring treatment 13. Fever above 38 degree Celsius 14. A possibility of pregnancy or during pregnancy, or lactating women 15. Psychosis or psychotic symptoms 16. Continuous systemic administration of steroids (oral or intravenous) 17. Hypersensitivity to ingredients of irinotecan or trastuzumab
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