drugset / Trial / NCT06324058

Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

NCT06324058

Unknown 190 enrolled Huashan Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups.

Timeline

Start
2024-03-18
Primary completion
2025-03-18
Completion
2026-03-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacillus Calmette-Guérin Vaccine Intravenous