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