ISRCTN14498712进行中（未招募）2 期
A phase II, open-label, multi-centre, multi-national interventional trial to evaluate the efficacy and safety of erdafitinib (ERDA) monotherapy and ERDA and cetrelimab combination as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer whose tumours express FGFR gene alterations
Spanish Oncology Genitourinary Group0 个研究点目标入组 600 人开始时间: 2023年4月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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
- 性别
- All
入选标准
- •1. Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study
- •2. Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a diagnostic or maximal TURBT performed no later than 3 months prior to start the screening visit
- •3. Pure or predominant (=50%) UC histology as determined at the local site
- •4. Age = 18 years
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •6. Decline or ineligible (unfit”) for cisplatin-based chemotherapy
- •7. Presence of a selected FGFR alteration on analysis of tumour biopsy
- •8. Adequate organ function
- •9. No other malignancy
- •10. Willingness to avoid pregnancy or fathering children
排除标准
- •1. Clinical evidence of N2-N3 tumours or metastatic bladder cancer
- •2. Has tumour with any neuroendocrine or small cell component
- •3. Patients who are not considered fit for cystectomy or reject cystectomy
- •4. Prior FGFR-targeted or antiPD1/PDL1 systemic therapy
- •5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer
研究者
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