EUCTR2017-003565-10-DE进行中（未招募）1 期
eoadjuvant and adjuvant durvalumab in combination with neoadjuvant chemotherapy in patients with operable urothelial cancer. A multicenter, single-arm phase II Trial.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- histologically proven urothelial cell carcinoma of the bladder, urethra or upper urinary tract and considered suitable for curative multimodality treatment including surgery by a multidisciplinary tumor board
- •- all histological subtypes eligible if urothelial carcinoma predominant
- •- WHO performance Status 0-1
- •- adequate bone marrow, hepatic, renal and cardiac function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •- pathological evidence of small-cell carcinoma component
- •- presence of distant metastasis
- •- previous Treatment with a PD-1 or PD-L1 Inhibitor, including durvalumab
- •- current or prior use of immunosuppressiva medication within 28 days prior to Registration
- •- active or prior documented autoimmune or inflammatory disorders
- •- known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B virus infection
研究者
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