Multicenter Phase II Study of Gemcitabine/Cisplatin (GC) Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) in the Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- pathological complete response rate
研究概览
简要总结
Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bladder cancer of T2-4aN0M0
- •upper tract urinary carcinoma of T1-3N0M0 and high grade
- •good organ function
- •no previous chemotherapy or immunotherapy
- •Informed consent form signed
排除标准
- •unable to receive chemotherapy or surgery due to physical abnormalities
- •previous cancer history
- •active tuberculosis
- •autoimmune disease
- •anticipating other clinical studies
研究组 & 干预措施
MIBC Group
Muscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients.
干预措施: Toripalimab (Drug)
UTUC Group
Upper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients.
干预措施: Toripalimab (Drug)
结局指标
主要结局
pathological complete response rate
时间窗: through study completion of 3 years
the percentage of pT0N0 patients after operations
次要结局
未报告次要终点
研究者
Jianzhong Shou
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
