AzTrials
AzTrials

Bladder CancerNCT07907575

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

A study testing ERBT and Adjuvant MMC Therapy and ERBT in people with Bladder Cancer, run by Chinese University of Hong Kong at 2 sites in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
ERBT and Adjuvant MMC Therapy and ERBT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
2 sitesHong Kong
Study dates
1 Jan 2027to 31 Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuen Chun Jeremy O TEOH, MD contact

35053933

jeremyteoh@surgery.cuhk.edu.hk

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

About this study

Official title: A Randomised Trial Investigating The Role of En Bloc Resection of Bladder Tumour Plus Adjuvant Intravesical Induction and Maintenance Chemotherapy for Intermediate-Risk Non-Muscle-Invasive Bladder Cancer

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.

Read the detailed description

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.

Conditions
Bladder Cancer
Being tested
ERBT and Adjuvant MMC Therapy, ERBT
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERBT and Adjuvant MMC TherapyDrug

    Also called Adjuvant Intravesical Induction plus Maintenance MMC

    Subject will receive 1-year of Ad-MMC after ERBT

  • ERBTProcedure or surgery

    Also called No adjuvant Treatment

    Subject will undergo ERBT

Study groups in NCT07907575
Study groupRoleWhat they receive
ERBT and Ad-MMC groupExperimentalSubject 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
Receives: Drug: ERBT and Adjuvant MMC Therapy
ERBT GroupActive comparatorNo Adjuvant treatment
Receives: Procedure: ERBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence free survival

    Measured: At Year 2

Secondary outcomes (4)

  1. Progression-free survival

    Measured: At Year 2

  2. Cancer-specific survival

    Measured: At Year 2

  3. Overall survival

    Measured: At Year 2

  4. Adverse event

    Assessed by Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: On Day 30 after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07907575
Sponsor's protocol ID
CRE 2026.015
Status last verified
Oct 2026
First submitted
25 Oct 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Teoh JY, Huang J, Ko WY, Lok V, Choi P, Ng CF, Sengupta S, Mostafid H, Kamat AM, Black PC, Shariat S, Babjuk M, Wong MC. Global Trends of Bladder Cancer Incidence and Mortality, and Their Associations with Tobacco Use and Gross Domestic Product Per Capita. Eur Urol. 2020 Dec;78(6):893-906. doi: 10.1016/j.eururo.2020.09.006. Epub 2020 Sep 21.

    PubMed 32972792

  • Yun EJ, Meng MV, Carroll PR. Evaluation of the patient with hematuria. Med Clin North Am. 2004 Mar;88(2):329-43. doi: 10.1016/S0025-7125(03)00172-X.

    PubMed 15049581

  • Gontero P, Soria F; European Association of Urology NMIBC Guidelines Panel. Reply to Francesco Montorsi, Giuseppe Rosiello, Giorgio Gandaglia, Andrea Salonia and Alberto Briganti's Letter to the Editor re: Paolo Gontero, Alison Birtle, Otakar Capoun, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ)-A Summary of the 2024 Guidelines Update. Eur Urol 2024;86:531-49. Eur Urol. 2025 May;87(5):e94-e95. doi: 10.1016/j.eururo.2025.02.021. Epub 2025 Mar 11. No abstract available.

    PubMed 40074642

  • Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.

    PubMed 16442208

  • Mariappan P, Johnston A, Padovani L, Clark E, Trail M, Hamid S, Hollins G, Simpson H, Thomas BG, Hasan R, Bhatt J, Ahmad I, Nandwani GM, Mitchell IDC, Hendry D; for members of the Scottish Bladder Cancer QPI Research Collaborative. Enhanced Quality and Effectiveness of Transurethral Resection of Bladder Tumour in Non-muscle-invasive Bladder Cancer: A Multicentre Real-world Experience from Scotland's Quality Performance Indicators Programme. Eur Urol. 2020 Oct;78(4):520-530. doi: 10.1016/j.eururo.2020.06.051. Epub 2020 Jul 17.

    PubMed 32690321

  • Teoh JY, Kamat AM, Black PC, Grivas P, Shariat SF, Babjuk M. Recurrence mechanisms of non-muscle-invasive bladder cancer - a clinical perspective. Nat Rev Urol. 2022 May;19(5):280-294. doi: 10.1038/s41585-022-00578-1. Epub 2022 Mar 31.

    PubMed 35361927

  • Ausfeld R, Beer M, Muhlethaler JP, Bartlome F, Widmer R, Tscholl R. Adjuvant intravesical chemotherapy of superficial bladder cancer with monthly doxorubicin or intensive mitomycin. A comparison of two consecutive series. Eur Urol. 1987;13(1-2):10-4. doi: 10.1159/000472727.

    PubMed 3582437

Questions about this trial

What is this clinical trial studying?

A study testing ERBT and Adjuvant MMC Therapy and ERBT in people with Bladder Cancer, run by Chinese University of Hong Kong at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuen Chun Jeremy O TEOH, MD (35053933, jeremyteoh@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence free survival (time frame: At Year 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07907575, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in