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临床试验/NCT04099589
NCT04099589Unknown2 期

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianzhong Shou

Professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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