An interventional study of ERBT and Adjuvant MMC Therapy and ERBT in Bladder Cancer, sponsored by Chinese University of Hong Kong. Not yet recruiting at 2 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
All consecutive patients with bladder tumour(s) who underwent ERBT will be screened for study eligibility. Imaging will be arranged to rule out any upper urinary tract malignancy. Patients are randomized to receive either 1-year adjuvant intravesical induction and maintenance chemotherapy or no adjuvant treatment with an allocation ratio of 1:1. After randomization, patients will receive induction course of intravesical mitomycin C within 4 weeks. The induction course consists of six weekly doses of intravesical mitomycin C (40mg mitomycin C). Afterwards, patients will receive ten monthly doses of intravesical mitomycin C (40mg mitomycin C) up to one year as maintenance course. The whole induction and maintenance course of Ad-MMC lasts for about one year. For both groups, surveillance flexible cystoscopy will be performed at a 3-month interval until 2 years after the index surgery, and then every 6 months for another 3 years. Biopsy will be taken and TURBT will be offered if there is any suspicious tumour recurrence noted during surveillance cystoscopy. Primary outcome is recurrence-free survival at 2 years.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 440 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject will receive induction course of intravesical mitomycin C within 4 weeks after ERBT. The induction course consists of six weekly doses (+/-2 days) of intravesical mitomycin C (40mg mitomycin C). Afterwards, patients will receive ten monthly (+/-7 days) doses of intravesical mitomycin C (40mg mitomycin C) up to one year as maintenance course. The whole induction and maintenance course of Ad-MMC lasts for about one year
Drug: ERBT and Adjuvant MMC Therapy
No Adjuvant treatment
Procedure: ERBT
Subject will receive 1-year of Ad-MMC after ERBT
Also known as: Adjuvant Intravesical Induction plus Maintenance MMC
Subject will undergo ERBT
Also known as: No adjuvant Treatment
Recurrence free survival
Time frame: At Year 2
Progression-free survival
Time frame: At Year 2
Cancer-specific survival
Time frame: At Year 2
Overall survival
Time frame: At Year 2
Adverse event
Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: On Day 30 after operation
Plan to share: No
Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.
Of 235 non-industry interventional studies with no phase under Urinary Bladder Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 70. This study's planned 35 months is below that.
Counting every sponsor, half of 244 studies reached it within 39 months; a quarter within 20 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →