This is a prospective, open label, single center clinical study on the use of recombinant human adenovirus type 5 injection for bladder instillation therapy in high-risk non muscle invasive bladder urothelial carcinoma patients. The study was administered in a dose escalation manner, starting from a relatively safe dose of 1.0 × 10 \^ 12vp as the first dose group, and a 6-week DLT observation period was set up to ensure the safety of the study. Expected to enroll 12-18 participants. The subjects need to undergo maximum transurethral resection of the bladder (TURBT) and imaging diagnosis, and biological samples such as blood, urine, and biopsy tissue should be collected before treatment. The patient will receive bladder instillation therapy with recombinant human adenovirus type 5 injection after TURBT surgery. The subjects should receive a fixed dose of recombinant human adenovirus type 5 injection (1.0 × 10 \^ 12 vp or 2.0 × 10 \^ 12 vp or 3.0 × 10 \^ 12 vp) per week via bladder instillation for 6 weeks for induction therapy, followed by maintenance infusion of the same dose once a week for 3 weeks after the first induction infusion at 3, 6, 12, 18, and 24 months. After the first intravesical intervention for 3 months, tumor site pathology, imaging, and cytology will be obtained through diagnostic TURBT for tumor evaluation. Patients who achieve complete remission will maintain the same induction cycle, and will receive follow-up every 3 months for 2 years, every 6 months for more than 2 years, and once a year for more than 3 years. Patients who are intolerant to intravesical treatment (evaluated by the researchers) will be directly discontinued.
Voluntarily participate in this clinical study, understand the study procedures, and provide written informed consent.
Aged ≥18 years, regardless of gender.
Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
Expected survival time ≥2 years.
Prior Bladder Radiotherapy
Prior Treatments Without Disease Progression (as Assessed by Investigator)
Previous intravesical therapy with cytotoxic chemotherapy or other agents (e.g., oncolytic viruses, IL-2).
Systemic chemotherapy, immune checkpoint inhibitors, or antibody-drug conjugates (ADCs).
RenJi Hospital
Lead sponsor