Not yet recruiting NCT07907575

The Role of ERBT Plus Adjuvant Intravesical Induction and Maintenance Chemotherapy for Intermediate-Risk NMIBC

Bladder / Urothelial CancerN/AStage III

This is a prospective, multi-centre randomised trial comparing between ERBT plus 1-year of Ad-MMC, versus ERBT alone, in treating intermediate-risk NMIBC.

Conditions: Bladder Cancer

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years old with informed consent
  • ERBT was successfully performed with clear resection margins
  • Histologically confirmed intermediate-risk NMIBC
  • Patients who are ineligible or refused to undergo intravesical BCG therapy

Exclusion Criteria

  • Any prior use of intravesical induction and/or maintenance chemotherapy instillations
  • Any prior use of intravesical BCG therapy
  • Presence or prior history of upper urinary tract malignancy
  • Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block) (20)
  • Presence of GOLD Stage III or IV chronic obstructive pulmonary disease (21)
  • ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities)
  • Pregnancy
  • Presence of other active malignancy

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年11月5日.