Toripalimab Combined With Intravesical Gemcitabine as Adjuvant Therapy for High-Risk Non-Muscle-Invasive Bladder Cancer After TURBT

Summary

This is a prospective, open-label, single-center, single-arm phase II clinical study to evaluate the efficacy and safety of toripalimab combined with intravesical gemcitabine as adjuvant therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). Patients with high-risk NMIBC are planned to be enrolled. Treatment consists of one immediate intravesical instillation of gemcitabine after TURBT, followed by induction intravesical chemotherapy with gemcitabine for 4-8 instillations, and then maintenance treatment with toripalimab combined with intravesical gemcitabine 2000 mg once monthly for 12 instillations.

Timeline

Start

2026-10-01

Primary completion

2028-10-01

Completion

2031-10-01

Drugs

Indications