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

NCT06388720 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-05-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Mitomycin-C

Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.

DRUG

gemcitabine

Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.

Sponsors & Collaborators

  • Korea University Anam Hospital

    collaborator OTHER

  • Pusan National University Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Seoul St. Mary's Hospital

    collaborator OTHER

  • Chonnam National University Hospital

    collaborator OTHER

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Ho Kyung Seo, MD · National Cancer Center, Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06388720 on ClinicalTrials.gov