JPRN-UMIN000034222已完成1 期
A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer - A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer (Ni-HIGH study)
The Cancer Institute Hospital of JFCR0 个研究点目标入组 45 人开始时间: 2018年9月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
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 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients who; 1) have complication or history of severe hypersensitive reactions against any antibody products 2)have any active double cancer with less than 5 years of disease-free interval 3)have any active infection diseases 4)have any of heart diseases or conditions within 6 months before registration; 5)are breastfeeding or not ruled out the potency of pregnancy prior to registration 6)not acknowledge for the birth control minimum 5 months for women and 7months for men after the latest last administration 7)have dyspnea at rest due to lung metastasis or cardiovascular diseases 8)have metastatic lesions in brain or meninges 9)have diarrhea 10)have concomitant of autoimmune diseases, or history of chronic or recurrent autoimmune diseases 11)require the administrations of systemic adrenocortical hormone or immunosuppresses, or had treated by them within 28 days before registration.
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