drugset / Trial / NCT05580354

Safety and Efficacy of BCG Combined With Tislelizumab for BCG-untreated Patients With High-risk Non-muscle Invasive Bladder Cancer

NCT05580354

Phase 4 Unknown 42 enrolled Ruijin Hospital
NaSingle-groupOpen-labelTreatment

Summary

For patients with high-risk non-muscle-invasive bladder cancer (NMIBC), intravesical therapy of BCG is the standard treatment proved to reduce the risk of recurrence and progression. However, there are patients failed to complete the whole treatment due to the long period and some patients showed no response to BCG or suffered tumor progression after BCG treatment. The aim of this study is to examine the efficacy and safety of intravesical therapy of BCG combined with PD-1 monoclonal antibody as the treatment of high-risk NMIBC patients without BCG treatment. At the same time, transcriptome sequencing is used to analyze the correlation between the efficacy of the treatment and the level of immune cell infiltration and tumor molecular subtypes.

Timeline

Start
2022-10-09
Primary completion
2024-10-09
Completion
2025-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BCG Unknown 120 mg Other
Subject Tislelizumab Monoclonal antibody 200 mg