Carcinomes urothéliaux Des Voies excrétrices supérieures traitées en Vie réelle Par immunothérapie (VESUVIO) : étude rétrospective Nationale
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 主要终点
- Overall survival on anti-PD-(L)1 immunotherapy
研究概览
简要总结
Upper-tract urothelial carcinoma (UTUC) is a rare tumor. Standard treatment of localized disease is most often radical nephroureterectomy.
In advanced/metastatic disease, treatments follow the standards for urothelial carcinoma including platinum-based chemotherapy and anti-PD(L)1 (Programmed death (ligand) 1) immunotherapy, with no regard as to the primary disease site (bladder or upper tract). Given the rarity of UTUC, efficacy data in the UTUC subgroup of advanced urothelial carcinoma is scarce.
UTUC show distinct pahological and molecular features, including higher prevalence of microsatellite instability and of abnormalities in the FGFR (fibroblast growth factor receptors) gene family. These specific features may impact outcomes of immunotherapy in advanced/metastatic UTUC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and more
- •Diagnosis of urothelial carcinoma (with or without variant histology)
- •Advanced/metastatic disease not amenable to local treatment with curative intent
- •Treatment with an anti-PD-(L)1 monoclonal antibody initiated between 2016 and 2022
排除标准
- •Patient's opposition to this research
- •Urothelial carcinoma of bladder or urethral primary site
- •Non-urothelial tumor
- •Maintenance immunotherapy initiated without disease progression
结局指标
主要结局
Overall survival on anti-PD-(L)1 immunotherapy
时间窗: 2 years after immunotherapy initiation
次要结局
- Translational study of predictive biomarkers of efficacy(Up to 7 years after immunotherapy initiation)
- Reasons for treatment discontinuation(Up to 7 years after immunotherapy initiation)
- Overall survival(5 years after immunotherapy initiation)
- Progression free survival(3 years after immunotherapy initiation)
- Best Objective Radiologic Response(Up to 7 years maximum)
- Duration of immunotherapy treatment(Up to 7 years after immunotherapy initiation)