Actively Recruiting
Bladder-Sparing Treatment Strategies Versus Radical Cystectomy for Large-Volume Non-Muscle-Invasive Bladder Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-03-18
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bladder cancer is a common urinary system cancer, with a significant number of patients diagnosed with non-muscle-invasive bladder cancer (NMIBC). NMIBC varies in risk based on tumor size, stage, and grade, and while surgery is primary treatment, residual tumors and recurrence are concerns, especially for larger tumors. This research aims to explore bladder-sparing treatment strategies for large-volume NMIBC, balancing quality of life with cancer control outcomes. The study compares two approaches: a bladder-sparing set and immediate radical cystectomy. The bladder-sparing method involves neoadjuvant chemotherapy combined with immunotherapy, followed by maximal transurethral resection of bladder tumor (TURBT) and a second TURBT, then mitomycin C bladder instillation therapy. The radical cystectomy group undergoes surgery immediately after three cycles of neoadjuvant therapy. Participants will be monitored from enrollment through three years after treatment, focusing on recurrence-free survival as the main outcome. Progression-free survival is also measured. Regular follow-up will assess tumor status and safety. The study includes adults aged 18 to 80 who can tolerate chemotherapy and immunotherapy and are willing to comply with study requirements, including ongoing evaluations and bladder instillation therapy.
CONDITIONS
Brief Title
A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of large non-muscle-invasive bladder cancer with tumor size 5 cm or larger, up to 3 tumors, VI-RADS score less than 3 before TURBT, or biopsy confirming non-muscle-invasive urothelial carcinoma.
- Ability to tolerate neoadjuvant chemotherapy and immunotherapy with sufficient heart, bone marrow, liver, and kidney function within clinical trial normal values.
- ECOG performance status of 0 or 1.
- No history of other malignancies.
- Able to receive regular mitomycin C bladder instillation therapy after TURBT.
- Male or female aged 18 to less than 80 years.
- Voluntary participation with informed consent and ability to comply with study and follow-up requirements.
You will not qualify if you...
- Preoperative imaging showing VI-RADS score 3 or higher.
- Postoperative pathology showing non-urothelial carcinoma or muscle-invasive urothelial carcinoma (stage T2 or higher).
- Presence of lymph node or distant metastases.
- Allergy or hypersensitivity to treatment drugs or presence of autoimmune diseases.
- Any condition assessed by the investigator as harmful or preventing study participation or compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of neoadjuvant therapy plus procedures and instillation therapy as per protocol
Participants receive neoadjuvant chemotherapy combined with immunotherapy followed by either bladder sparing procedures with mitomycin C bladder instillation therapy or radical cystectomy.
Multiple visits for neoadjuvant therapy, surgery, and bladder instillation therapy
Duration - Up to 3 years post-treatment completion
Participants are monitored for recurrence-free and progression-free survival up to 3 years after treatment completion.
Regular follow-up visits according to study schedule
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
Q
Qiang Cao, PhD
C
chenghao wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here