JPRN-UMIN000022007已完成2 期
Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma; PRIMER trial - Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma
ational Cancer Center0 个研究点目标入组 15 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- •1)Patients with active double cancer (except for completely resected basal cell cancer, stage I squamous cell cancer, carcinoma in situ, intramucosal cancer, superficial bladder cancer, or gastrointestinal cancer resected by ESD or EMR, or other cancer free of relapse for 5 years) 2)Patients who have an infection requiring systematic therapy 3)Patients with active gastrointestinal ulceration 4)Patients with current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings 5)Patients with a current or previous severe hypersensitive reaction to an antibody product 6)Patients with a current or chronic and recurrent auto immune disease (Patients could be enrolled if they had type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorder requiring no systematic therapy, or an auto immune disease predicted to remain free of disease in the absence of external factors) 7)Patients who are HIV antibody-positive, HBsAg-positive, or HCV antibody-positive (even though a patient was HCV antibody-positive, the patient could be enrolled if the patient was HCV-RNA-negative) 8)Patients who are HBsAg-negative, but HBs antibody-positive or HBc antibody-positive, and HCV-DNA quantitative test is positive 9)Pregnant or breast-feeding women, or women suspected of being pregnant 10)Patients with a psychiatric disease or psychological symptoms
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