JPRN-UMIN000025560已完成1 期
A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer - A multicenter, phase 1/2 study of Ramucirumab plus Nivolumab as second-line therapy in participants with gastric or GEJ cancer
Department of Head and Neck Oncology, National Cancer Center Japan Hospital0 个研究点目标入组 46 人开始时间: 2017年1月6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
- 46
研究概览
简要总结
46 advanced gastric cancer patients (median age 66 years) were enrolled. No dose limiting toxicities were observed in the phase 1 part. With median follow up time of 10.2 month, 6-month progression free survival rate was 37.4% (90% confidential intervals: 25.7-49.2%), which met the primary endpoint of the phase 2 part. objective responce rate/disease responce rate were 26.7%/62.2%. Median progression free survival/overall survival were 2.9/9.0 months.
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 have double cancer - Patients have infection required systemic therapy - Known central nervous system (CNS) metastasis - Patients with history of pneumonitis or pulmonary fibrosis - Patients with history of serious anaphylaxis induced by antibody preparation - Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease - Female who is pregnant, lactating or suspected pregnancy - Patients with psychosis or dementia to interfere to obtain informed consent appropriately
研究者
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