This is an experimental study to evaluate the efficacy and safety of VT-101 for the treatment of non-muscle invasive bladder cancer
Age 18-75 years old (including 18 and 75 years old), male or female;
Patients with non-muscle-invasive bladder cancer (NMIBC) confirmed by histopathological examination results (pathological stage: high-grade Ta or any T1 level papillary carcinoma or cystoscopic random biopsy confirmed presence of bladder in situ carcinoma (CIS) (with or without papillary carcinoma): according to the results of the biopsy taken within 8 weeks before the first treatment according to the study. If multiple bladder biopsies are needed to confirm eligibility, the last biopsy must be taken within 8 weeks.
T1 HG/G3 tumors without CIS and not eligible for the very high risk group
Tumors present CIS and do not meet the conditions of the very high risk group
A current or past history of muscular invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer;
Urothelial carcinoma of the upper urogenital tract (kidney, renal collecting system, ureter) or prostatic urethra (including urethral CIS) in the 24 months prior to enrollment;
Cystoscopy orimaging examination confirmed the current bladder perforation;
Prior systemic treatment, radiation therapy, or surgery for bladder cancer during screening, in addition to TURBT or bladder biopsy. Intravesical perfusion within 8 weeks prior to initiation of study therapy, with the exception of a single infusion of cytotoxic drugs (e.g. mitomycin C, gemcitabine, pirarubicin, and epirubicin) immediately after TURBT surgery;
The Affiliated Hospital of Xuzhou Medical University
Lead sponsor
Xuzhou Medical University
Collaborator