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Recruiting Phase 1 NCT06632964

A Clinical Trial Aimed At Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer

Trial Parameters

Condition Non-muscle Invasive Bladder Cancer
Sponsor The Affiliated Hospital of Xuzhou Medical University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 16
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-09-18
Completion 2025-09-01
Interventions
Recombinant oncolytic adenovirus injection solution of VT-101

Brief Summary

This is an experimental study to evaluate the efficacy and safety of VT-101 for the treatment of non-muscle invasive bladder cancer

Eligibility Criteria

Inclusion Criteria: 1. Age 18-75 years old (including 18 and 75 years old), male or female; 2. 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. For patients with high-risk disease at the second TURBT, defined as high-grade Ta/T1 lesions, the subject must completely remove all visible tumors before enrollment and be recorded at the baseline cystoscopy. The results of the cellular pathology examination for high-grade urothelial carcinoma must be negative before enrollment, excluding those with unresectable high-risk and ext

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