OncoMatch/Clinical Trials/NCT06388720
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
Is NCT06388720 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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.
Demographics
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.
Frequently asked questions
Is NCT06388720 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic cytotoxic chemotherapy, radiation therapy, Mitomycin-c or gemcitabine (intravesical) disqualifies patients from enrollment.
What disease stage is eligible?
Stage HIGH-GRADE TA or CIS or TA, LOW GRADE, AND MULTIPLE RECURRENCES OF MORE THAN 3 CM is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages