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Clinical Trials in South Korea / NCT06388720
Recruiting Phase 2

The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy

NCT06388720 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2024-11-19
Last updated
2026-05-29

Condition(s) studied

Bladder Cancer

Investigational drug(s) / intervention(s)

Mitomycin-C →gemcitabine →

Mitomycin-C: Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.

gemcitabine: Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.

Study summary

The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. a patient over the age of 20 2. Patients who are willing and able to complete a written test subject consent/approval for this examination. 3. Histologically confirmed high-risk NMIBC (according to AUA guidelines; High-grade T1 disease, any recurrent high-grade Ta, high-grade Ta \>3 cm, high-grade Ta that is multifocal, any carcinoma in situ, any BCG failure in high-grade patients, any variant histology, any lymphovascular invasion, and any high-grade prostatic urethral involvement) with prior BCG therapy. 4. The most recent bladder examination/TURBT must be performed within 8 weeks before the initial administration of the trial treatment. Patients with high risk NMIBC who received proper BCG treatment but did not respond to BCG 5. Patients who are not eligible for a radical bladder resection or who have refused surgery. 6. Patient who are not being pregnant or breast feeding until the study period. Exclusion Criteria: 1. Patient diagnosed with muscle-invasive bladder cancer at TURBT 2. If upper urinary tract urothelial cancer is accompanied by imaging 3. If the imaging indicates extravesical involvement (cT3) 4. Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis 5. In a biopsy, non-transitional cell histology is dominant, or only non-transitional cell tissue is present (primary squamous cell carcinoma, primary adenocarcinoma, small cell carcinoma, sarcoma, carcinosarcoma, paraganglioma, melanoma, lymphoma) 6. In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years 7. If patient have a history of pelvic radiation therapy for other cancers within 3 years 8. If patient have a history of receiving Mitomycin-c or gemcitabine in the bladder within 3 years. The exception is cases used for the purpose of injection therapy of anticancer drugs in the early bladder cancer 9. If patient has a history of allergy to mitomycin-c or gemcitabine 10. Cystoscopy shows a tumor in the prostate urethra 11. Patients who have participated in studies using clinical trial drugs and are currently receiving clinical trial drugs or who have used clinical trial drugs or clinical trial medical devices within 4 weeks prior to the date of initial treatment 12. After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior to the start of trial treatment 13. Thrombocytopenia, coagulopathy or bleeding tendency patient. 14. Pregnant or breast-feeding women 15. If patient treated yellow fever vaccine or phenytoin 16. Dysfunction of liver or kidney (GFP≤30) 17. If patient undergo severe myelosuppression 18. If patient complicated severe infection 19. If patient definitely diagnosed interstitial lung disease or lung fibrosis by chest X-ray. 20. If patient conduct chest radiotherapy.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Cancer Center Goyang-si South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06388720 on ClinicalTrials.gov ↗ ← All trials in South Korea