Status:
NOT_YET_RECRUITING
Efficacy of Gemcitabine Submucosal Injection for Preventing Recurrence in Intermediate- and High-Risk Non-Muscle-Invasive Bladder Cancer: A Randomized Trial
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Conditions:
Non Muscle Invasive Bladder Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Bladder cancer is the most common malignant tumor of the urinary system in China, and its incidence has been increasing year by year. It is classified into non-muscle-invasive bladder cancer (NMIBC) a...
Detailed Description
Bladder cancer is a common malignant tumor of the urinary system. Globally, in 2023, there were approximately 610,000 new cases of bladder cancer and about 220,000 deaths attributed to the disease. In...
Eligibility Criteria
Inclusion
- Patients aged 18 to 80 years (inclusive) with radiologically confirmed bladder tumor and scheduled to undergo transurethral resection of bladder tumor (TURBT).
- Postoperative pathological confirmation of intermediate- or high-risk non-muscle-invasive bladder cancer (NMIBC).
- Voluntarily participate in the study and sign the informed consent form, ensuring the patient fully understands the trial purpose, risks, and right to withdraw.
Exclusion
- Preoperative comorbidities including detrusor overactivity, urethral stricture, urge incontinence, stress incontinence, or overflow incontinence.
- Concurrent urogenital infectious diseases (e.g., acute urethritis, acute cystitis).
- History of pelvic radiotherapy.
- Receiving systemic anti-tumor therapy for any malignant tumor.
- Severe cardiovascular disease, hepatic or renal insufficiency, or coagulation dysfunction.
- Presence of mental illness or psychological disorders that impair normal communication.
- Any other situation deemed by the investigator as unsuitable for participation in this clinical study.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT07198451
Start Date
October 1 2025
End Date
June 1 2028
Last Update
September 30 2025
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