Spots Global Cancer Trial Database for Safety and Efficacy of Toripalimab for Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma

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Trial Identification

Brief Title: Safety and Efficacy of Toripalimab for Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma

Official Title: A Phase II, Open, Multi-center and Single Arm Study Investigating Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Injection in Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma

Study ID: NCT03113266

Conditions

Bladder Urothelial Carcinoma

Interventions

humanized anti-PD-1 monoclonal antibody toripalimab

Study Description

Brief Summary: This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with locally advanced or metastatic bladder urothelial carcinoma who have failed in routine systemic treatment.

Detailed Description: This is a multi-center, open-label, phase 2 study evaluating the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with locally advanced or metastatic bladder urothelial carcinoma who have failed in routine systemic treatment.The implementation of study meet the GCP.370 patients will be enrolled in the study to evaluate the safety and efficacy of JS001.Patients are injected with JS001 with 3mg/kg every 2 weeks until disease progresses or unacceptable toxicity occurs.Response assessment is conducted by every 8 weeks in first year, every 12 weeks in second year and every 16 weeks in third year and beyond.