drugset / Trial / NCT04211012
A Study on Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Urothelial Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, open-label,phase II study designed to evaluate the efficacy and safety of Toripalimab plus nab-paclitaxel with or without cisplatin as first-line treatment of unresectable locally advanced or metastatic urothelial carcinoma.Each enrolled Patient will receive Toripalimab plus nab-paclitaxel with or without cisplatin until progressive disease or intolerable toxicity occurs, then enter a survival follow-up period. Nab-paclitaxel with or without cisplatin will be administered for up to 6 cycles, and Toripalimab up to 2 years.
Timeline
- Start
- 2020-11-30
- Primary completion
- 2022-01-30
- Completion
- 2023-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |