JPRN-jRCTs041210108招募中未知
A multicenter randomized clinical trial of ipilimumab plus nivolumab with prophlactic dexamethasone therapy in patients with advanced renal cell carcinoma comparing with a historical control trearted with traditional ipilimumab plus nivolumab therapy.
Hamamoto Shuzo0 个研究点目标入组 90 人开始时间: 2021年11月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 90
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
- >= 20age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •(1) 20-90 years old patients who were diagnosed as advanced renal cell carcinoma and had an indication for Ipilimumab plus nivolumab therapy
- •(2) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1, 2, or 3
- •(3) labolatory data includes the following criteria
- •a) WBC: more than 3,000 /mm3
- •b) Hb: more than 8.0g/dL
- •c) PLT: more than 100000/mm3
- •d) AST(GOT), ALT(GPT): AST Less than 66 mg/dL, ALT Less than 54 mg/dL
- •e) Total Bil: Less than 1.5mg/dL
- •(4) Patients who can get hospitalized for this study
- •(5) Patients who were obtained written informed consent
排除标准
- •(1) women with pregnant or its possibily
- •(2) Hisory of Having allegies to ipilimumab or nivolumab therapy
- •(3) active multiple cancer
- •(4) Taking a steroid or immunosuppressive drug
- •(5) uncontoralble diabetes
- •(6) Judged as an inappropriate patient by the investigator or sub-investigator
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