JPRN-jRCTs051180102已完成2 期
Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma - URivO
akano Yuzo0 个研究点目标入组 141 人开始时间: 2019年3月7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
- 141
研究概览
简要总结
The study was discontinued because it was judged inappropriate to continue the study due to inappropriate cases in the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •Advanced renal cell carcinoma with unresectable or metastatic history who had been treated with tyrosine kinase inhibitors
- •Patients who have at least one tumorous lesion of 10 mm over in CT/ MRI and evaluated with RECIST ver1.1
- •Nuetrphils >= 1500 cells/mm3, platelets >= 75000 cells/mm3, hemoglobin >= 9.0 g/dl, AST <= 78IU/l, ALT <= 85IU/l, total bilirubin <= 1.5 mg/dl, serum creatinine <= 2.0 mg/dl
- •Over 20 years old patients
- •written informed consent
排除标准
- •Patients who have been administered immune checkpoint inhibitors including nivolumab in the past
- •Patients with active infection of bacteria, fungi or viruses
- •Patients who have a history of malignant tumors other than renal cell carcinoma and are judged not to be cured
- •Patients suffering from other severe acute or chronic diseases
- •Pregnant women or women who may be pregnant or lactating women
- •Patients complicated with psychiatric disorders or psychiatric symptoms and judged to be difficult to participate in the study
- •Patients found to be unacceptable to components of test drugs (or excipients)
- •For other reasons, patients who judged ineligible for participation in this study by physician
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