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

Inclusion Criteria:

1. a patient over the age of 20

2. Patients who are willing and able to complete a written test subjectconsent/approval for this examination.

3. Patients with histological confirmation of high-risk non-muscle infiltration (T1,high-grade Ta and/or CIS) bladder transition cell cancer. However, according to thedefinition of EAU guidelines high-risk NMIBC, Ta, low grade, and multiplerecurrences of more than 3 cm are included.

4. The most recent bladder examination/TURBT must be performed within 8 weeks beforethe initial administration of the trial treatment. Patients with high risk NMIBC whoreceived proper BCG treatment but did not respond to BCG

5. Patients who are not eligible for a radical bladder resection or who have refusedsurgery.

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-transitionalcell 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 3years

7. If patient have a history of pelvic radiation therapy for other cancers within 3years

8. If patient have a history of receiving Mitomycin-c or gemcitabine in the bladderwithin 3 years. The exception is cases used for the purpose of injection therapy ofanticancer 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 arecurrently receiving clinical trial drugs or who have used clinical trial drugs orclinical trial medical devices within 4 weeks prior to the date of initial treatment

12. After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior tothe 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 chestX-ray.

20. If patient conduct chest radiotherapy.