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Not Yet Recruiting NCT07724886

Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC

Conditions: Bladder Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 732
Sponsor: Chinese University of Hong Kong

Location: Prince of Wales Hospital Hong Kong

Summary

This is a prospective, multi-centre randomised trial comparing between cTURBT plus 1-year BCG therapy, and ERBT plus 1-year BCG therapy, in patients with intermediate-risk or high-risk NMIBC.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or above * Fulfil any one of the following three criteria: 1. Recurrent bladder tumour 2. Multiple bladder tumours 3. Any bladder tumour size of \>1cm Exclusion Criteria: * EAU low-risk NIMBC as intravesical BCG therapy should not be offered (5) * EAU very high-risk NMIBC as upfront radical cystectomy should be offered (5) * 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) (16) * Presence of GOLD Stage III or IV chronic obstructive pulmonary disease * ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities) (18) * History of bleeding disorder or use of anti-coagulants * Pregnancy * Presence of other active malignancy

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07724886). StuddyBuddy aggregates publicly available trial information.