Efficacy of Gemcitabine Submucosal Injection for Preventing Recurrence in Intermediate- and High-Risk Non-Muscle-Invasive Bladder Cancer: A Randomized Trial

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

June 30, 2028

Conditions
Non Muscle Invasive Bladder Cancer
Interventions
DRUG

Gemcitabine Submucosal Injection

A chemotherapeutic agent. Administered via submucosal injection into the bladder wall using a specialized injection gun. Dosage: 1000mg per injection. Regimen: One injection immediately post-TURBT, followed by one injection every three months for a total of four injections.

DRUG

Gemcitabine Intravesical Instillation

Standard therapy. Administered by instilling a solution into the bladder via a catheter. Dosage: 2000mg dissolved in 50mL normal saline per instillation. Regimen: One instillation immediately post-TURBT, followed by an induction phase (once weekly for 8 weeks) and a maintenance phase (once monthly for 10 months). The solution is retained for 30-60 minutes.

All Listed Sponsors
lead

Shanghai University of Traditional Chinese Medicine

OTHER