OncoMatch/Clinical Trials/NCT06388720
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
Is NCT06388720 recruiting? Yes, currently enrolling (Sep 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-RISK NMIBC, HIGH-GRADE T1, HIGH-GRADE TA, CARCINOMA IN SITU (other)
Excluded: Stage MUSCLE-INVASIVE BLADDER CANCER, EXTRAVESICAL INVOLVEMENT (CT3), LYMPH NODE METASTASIS, DISTANT METASTASIS
Grade: high-grade
Histologically confirmed high-risk NMIBC (according to AUA guidelines...) with prior BCG therapy
Demographics
Prior therapy
Must have received: BCG therapy — bladder cancer
any BCG failure in high-grade patients; Patients with high risk NMIBC who received proper BCG treatment but did not respond to BCG
Cannot have received: systemic cytotoxic chemotherapy
Exception: within 3 years
In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years
Cannot have received: pelvic radiation therapy
Exception: within 3 years
history of pelvic radiation therapy for other cancers within 3 years
Cannot have received: intravesical mitomycin-c or gemcitabine (mitomycin-c, gemcitabine)
Exception: cases used for injection therapy of anticancer drugs in 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); 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, pelvic radiation therapy, intravesical mitomycin-c or gemcitabine disqualifies patients from enrollment.
What disease stage is eligible?
Stage HIGH-RISK NMIBC or HIGH-GRADE T1 or HIGH-GRADE TA or CARCINOMA IN SITU 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