NL-OMON48706招募中2 期
eoadjuvant AXITINIB plus AVELUMAB for patients with localized RCC and a moderate to high risk of recurrence - NEOAVAX
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- 18 至 99（—）
入选标准
- •Signed and written informed consent
- •Male or female patients age >= 18 years
- •Histologically confirmed diagnosis of non-metastatic clear-cell renal cell
- •carcinoma of intermediate to high risk with completely resectable primary
- •World Health Organization (WHO) performance status of 0-1.
- •Adequate coagulation function as defined in protocol
- •Adequate hematological function as defined in protocol
- •Adequate hepatic function as defined in protocol
- •Adequate renal function as defined in protocol
- •Negative serum pregnancy test at screening for women of childbearing
排除标准
- •Renal tumors of low risk or M1
- •Clinically significant gastrointestinal abnormalities that may affect
- •absorption of investigational product
- •Major surgery or trauma within 28 days prior to first dose of investigational
- •product and/or presence of any non-healing wound, fracture, or ulcer
- •Administration of any non-oncologic investigational drug prior to receiving
- •the first dose of study treatment
- •Active autoimmune disease that might deteriorate when receiving an
- •immunostimulatory agent
- •Known severe hypersensitivity reactions to monoclonal antibodies
- •positive test for HBV or HCV
研究者
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