drugset / Trial / NCT04211012

A Study on Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Urothelial Carcinoma

NCT04211012 ↗

Phase 2 Unknown 30 enrolled Jun Guo
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

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 70 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 260 mg/m2 Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous

Indications