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

Exclusion Criteria20

• Patient diagnosed with muscle-invasive bladder cancer at TURBT
• If upper urinary tract urothelial cancer is accompanied by imaging
• If the imaging indicates extravesical involvement (cT3)
• Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis
• 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)
• In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years
• If patient have a history of pelvic radiation therapy for other cancers within 3 years
• 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
• If patient has a history of allergy to mitomycin-c or gemcitabine
• Cystoscopy shows a tumor in the prostate urethra
• 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
• After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior to the start of trial treatment
• Thrombocytopenia, coagulopathy or bleeding tendency patient.
• Pregnant or breast-feeding women
• If patient treated yellow fever vaccine or phenytoin
• Dysfunction of liver or kidney (GFP≤30)
• If patient undergo severe myelosuppression
• If patient complicated severe infection
• If patient definitely diagnosed interstitial lung disease or lung fibrosis by chest X-ray.
• If patient conduct chest radiotherapy.