Bladder (Urothelial, Transitional Cell) CancerPhase 3HERONCT07207824
DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
A Phase 3 study testing Active Comparator: BCG induction and maintenance and DV + BCG induction and maintenance in people with Bladder (Urothelial, Transitional Cell) Cancer and NMIBC, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
- What is being tested?
- Active Comparator: BCG induction and maintenance and DV + BCG induction and maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2030
- Phase
- Phase 3
- 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.
- Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with >50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).
- Complete resection of all Ta/T1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.
- HER2 expression (IHC 1+/2+/3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.
- Unwillingness or ineligibility to undergo radical cystectomy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
- Signed informed consent form (ICF).
Who cannot join
- Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.
- Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.
- History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).
- Prior therapy with any other type of HER2-targeted inhibitor.
- Major surgery within 2 weeks prior to randomization.
- Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200230
Dingwei Ye, Ph.D., 13817126663, dwyeli@163.com
About this study
Official title: A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.
Read the detailed description
HERO: A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined with Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients with HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer
This Phase 3, open-label, randomized, controlled clinical trial will enroll approximately 182 patients, who will be assigned in a 1:1 ratio to one of two treatment groups:
Group A: Disitamab Vedotin plus BCG (induction and maintenance therapy)
Group B: BCG alone (induction and maintenance therapy)
The study is designed to demonstrate the superiority of Disitamab Vedotin combined with BCG (during both induction and maintenance phases) over BCG alone in prolonging event-free survival (EFS) among BCG-naïve participants with high-risk, HER2-expressing non-muscle invasive bladder cancer.
- Being tested
- Active Comparator: BCG induction and maintenance, DV + BCG induction and maintenance
- Keywords
- NMIBC, disitamab vedotin, HER2, BCG
- Medical subject headings
- Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: BCG induction and maintenanceDrug
Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer
Other Names:
BCG
DV + BCG induction and maintenanceDrug
Drug: Disitamab vedotin(RC48) •An antibody-drug conjugates (ADCs) targeting HER2, has been approved in China for chemotherapy-refractory advanced UC with HER2-expression.
Other Names:
- RC48, DV
Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer
Other Names:
BCG
| Study group | Role | What they receive |
|---|---|---|
| DV + BCG | Experimental | Disitamab Vedotin + BCG induction and maintenance Receives: Drug: DV + BCG induction and maintenance |
| BCG | Active comparator | BCG induction and maintenance Receives: Drug: Active Comparator: BCG induction and maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Event free survival is defined as the time from randomization to date of EFS event.
Measured: 55 months after first participant randomized
Secondary outcomes (5)
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Measured: Randomization up to 60 months from last participant randomized
Complete response rate at 6m/12m in participants with CIS at randomization
Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.
Measured: Randomization up to 12 months from last participant randomized
Disease-specific survival
Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.
Measured: Randomization up to 60 months from last participant randomized
Health-related quality of life as measured by EORTC QLQ-C30
Health-related quality of life as measured by EORTC QLQ-C30
Measured: Randomization up to 60 months from last participant randomized
Health-related quality of life as measured by EORTC QLQ-NMIBC24
EORTC-QLQ-NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each).
Measured: Randomization up to 60 months from last participant randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Dec 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207824
- Sponsor's protocol ID
- RCVDUCIIR020-2
- Acronym
- HERO
- Status last verified
- Jan 2026
- First submitted
- 28 Sep 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data is protected.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07207824
- Acronym / sponsor ID
- HERO / RCVDUCIIR020-2
- Keywords
- NMIBC, disitamab vedotin, HER2, BCG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.
Detailed description
HERO: A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined with Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients with HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer
This Phase 3, open-label, randomized, controlled clinical trial will enroll approximately 182 patients, who will be assigned in a 1:1 ratio to one of two treatment groups:
Group A: Disitamab Vedotin plus BCG (induction and maintenance therapy)
Group B: BCG alone (induction and maintenance therapy)
The study is designed to demonstrate the superiority of Disitamab Vedotin combined with BCG (during both induction and maintenance phases) over BCG alone in prolonging event-free survival (EFS) among BCG-naïve participants with high-risk, HER2-expressing non-muscle invasive bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DV + BCG | Experimental | Drug: DV + BCG induction and maintenanceDisitamab Vedotin + BCG induction and maintenance |
| BCG | Active comparator | Drug: Active Comparator: BCG induction and maintenanceBCG induction and maintenance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with >50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).
- Complete resection of all Ta/T1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.
- HER2 expression (IHC 1+/2+/3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.
- Unwillingness or ineligibility to undergo radical cystectomy.
Key exclusion criteria (6 listed)
- Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.
- Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.
- History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).
- Prior therapy with any other type of HER2-targeted inhibitor.
- Major surgery within 2 weeks prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: BCG induction and maintenanceDrug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer Other Names: BCG | Drug | BCG |
| DV + BCG induction and maintenanceDrug: Disitamab vedotin(RC48) •An antibody-drug conjugates (ADCs) targeting HER2, has been approved in China for chemotherapy-refractory advanced UC with HER2-expression. Other Names: • RC48, DV Drug: Bacillus Calmette-Guerin Immunotherapy treatment approved by NMPA for patients with high-risk non-muscle invasive bladder cancer Other Names: BCG | Drug | DV + BCG |
Primary outcome
Event free survival
Time frame: 55 months after first participant randomized
Event free survival is defined as the time from randomization to date of EFS event.
5 secondary outcomes
Overall Survival
Time frame: Randomization up to 60 months from last participant randomized
Complete response rate at 6m/12m in participants with CIS at randomization
Time frame: Randomization up to 12 months from last participant randomized
Disease-specific survival
Time frame: Randomization up to 60 months from last participant randomized
Health-related quality of life as measured by EORTC QLQ-C30
Time frame: Randomization up to 60 months from last participant randomized
Health-related quality of life as measured by EORTC QLQ-NMIBC24
Time frame: Randomization up to 60 months from last participant randomized
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. Individual Participant Data is protected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active Comparator: BCG induction and maintenance and DV + BCG induction and maintenance in people with Bladder (Urothelial, Transitional Cell) Cancer and NMIBC, run by Fudan University at 1 site in China.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yi jun Shen, M.D. (862164175590, yijunshen@urocancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: 55 months after first participant randomized). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.