OncoMatch/Clinical Trials/NCT06388720
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
Is NCT06388720 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Mitomycin-C and gemcitabine for bladder cancer.
Treatment: Mitomycin-C · gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage HIGH-GRADE TA, CIS, TA, LOW GRADE, AND MULTIPLE RECURRENCES OF MORE THAN 3 CM (EAU guidelines)
Excluded: Stage MUSCLE-INVASIVE
Grade: high-grade, low grade (with multiple recurrences >3cm)
high-risk non-muscle infiltration (T1, high-grade Ta and/or CIS) bladder transition cell cancer. ... high-risk NMIBC, Ta, low grade, and multiple recurrences of more than 3 cm are included.
Prior therapy
Must have received: BCG therapy — bladder
Patients with high risk NMIBC who received proper BCG treatment but did not respond to BCG
Cannot have received: systemic cytotoxic chemotherapy
Exception: for other cancers within 3 years
In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years
Cannot have received: radiation therapy
Exception: pelvic radiation for other cancers within 3 years
history of pelvic radiation therapy for other cancers within 3 years
Cannot have received: Mitomycin-c or gemcitabine (intravesical) (mitomycin-c, gemcitabine)
Exception: cases used for the purpose of injection therapy of anticancer drugs in the early bladder cancer
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
Cannot have received: intravesical chemotherapy
After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior to the start of trial treatment
Lab requirements
Blood counts
Thrombocytopenia, coagulopathy or bleeding tendency patient; severe myelosuppression
Kidney function
Dysfunction of kidney (GFP≤30)
Liver function
Dysfunction of liver (GFP≤30)
Thrombocytopenia, coagulopathy or bleeding tendency patient. Dysfunction of liver or kidney (GFP≤30). If patient undergo severe myelosuppression
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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