Upper Urinary Tract Urothelial CarcinomaPhase 2HERO-UTUCNCT07591805
HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC
A Phase 2 study testing Drug: Disitamab Vedotin in people with Upper Urinary Tract Urothelial Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
This is a prospective, single-center, single-arm phase II study evaluating whether a single postoperative intravesical instillation of disitamab vedotin (RC48) can reduce bladder recurrence after radical nephroureterectomy (RNU) in patients with HER2-positive upper tract urothelial carcinoma (UTUC). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Upper Urinary Tract Urothelial Carcinoma
- What is being tested?
- Drug: Disitamab Vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2026to 31 Jan 2028
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Histologically or radiologically suspected UTUC planned for RNU
- HER2-positive tumor defined as IHC 1+, 2+, or 3+ on preoperative or surgical specimen testing.
- ECOG performance status 0-1.
- No prior or concomitant bladder urothelial carcinoma within 5 years.
- Adequate hematologic, hepatic, and renal function.
- Ability to comply with protocol-required surveillance.
- Written informed consent. -
Who cannot join
- 1.Evidence of metastatic disease before enrollment. 2.Prior treatment with disitamab vedotin. 3.Prior intravesical anti-cancer therapy within 12 months. 4.Active uncontrolled infection. 5.Pregnancy or breastfeeding. 6.Severe uncontrolled cardiovascular, pulmonary, hepatic, or systemic disease. 7.Known hypersensitivity to study drug components. 8.Any condition that, in the investigator's judgment, would compromise participation or interpretation.
- -
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
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: A Prospective Phase II Study of Single Postoperative Intravesical Disitamab Vedotin to Prevent Bladder Recurrence After Radical Nephroureterectomy in HER2-Positive Upper Tract Urothelial Carcinoma
This is a prospective, single-center, single-arm phase II study evaluating whether a single postoperative intravesical instillation of disitamab vedotin (RC48) can reduce bladder recurrence after radical nephroureterectomy (RNU) in patients with HER2-positive upper tract urothelial carcinoma (UTUC). Eligible patients will receive one intravesical instillation of RC48 within 96 hours after surgery. The primary objective is to determine the 12-month intravesical recurrence rate. Serial urine samples will be prospectively collected to evaluate urinary methylation biomarkers for early recurrence detection.
- Conditions
- Upper Urinary Tract Urothelial Carcinoma
- Being tested
- Drug: Disitamab Vedotin
- Keywords
- Upper Urinary Tract Urothelial Carcinoma, Bladder Recurrence, Disitamab Vedotin, Radical Nephroureterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Disitamab VedotinDrug
Participants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Intravesical Disitamab Vedotin Participants will receive a single postoperative intravesical instill | Experimental | Participants will receive a single postoperative intravesical instillation of 180mg disitamab vedotin within 96 hours after radical nephroureterectomy. Receives: Drug: Drug: Disitamab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Month Intravesical Recurrence Rate
Proportion of participants with histologically confirmed bladder urothelial recurrence within 12 months after radical nephroureterectomy.
Measured: 12 months
Secondary outcomes (5)
Intravesical Recurrence-Free Survival (IVRFS)
Time from radical nephroureterectomy to first histologically confirmed bladder recurrence.
Measured: Up to 24 months
Cumulative Incidence of Bladder Recurrence
Cumulative incidence of bladder recurrence with distant metastasis or death treated as competing events.
Measured: 12 months, 24 months
Metastasis-Free Survival (MFS)
Time from radical nephroureterectomy to distant recurrence or death from any cause.
Measured: Up to 24 months
Safety and Tolerability
Incidence, type, and severity of adverse events graded according to CTCAE version 5.0.
Measured: From treatment to 90 days after instillation
Feasibility of Intravesical RC48 Administration
Successful completion of planned intravesical administration without premature discontinuation or procedure-related serious complication.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start16 May 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Urinary Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wei xue, M.D, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591805
- Sponsor's protocol ID
- HERO-UTUC Trial
- Acronym
- HERO-UTUC
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Single Postoperative Intravesical Disitamab Vedotin to Prevent Bladder Recurrence After Radical Nephroureterectomy in HER2-Positive Upper Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07591805
- Acronym / sponsor ID
- HERO-UTUC / HERO-UTUC Trial
- Conditions
- Upper Urinary Tract Urothelial Carcinoma
- Keywords
- Upper Urinary Tract Urothelial Carcinoma, Bladder Recurrence, Disitamab Vedotin, Radical Nephroureterectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 16 May 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 18 May 2026 (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.
This is a prospective, single-center, single-arm phase II study evaluating whether a single postoperative intravesical instillation of disitamab vedotin (RC48) can reduce bladder recurrence after radical nephroureterectomy (RNU) in patients with HER2-positive upper tract urothelial carcinoma (UTUC). Eligible patients will receive one intravesical instillation of RC48 within 96 hours after surgery. The primary objective is to determine the 12-month intravesical recurrence rate. Serial urine samples will be prospectively collected to evaluate urinary methylation biomarkers for early recurrence detection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravesical Disitamab Vedotin Participants will receive a single postoperative intravesical instill | Experimental | Drug: Drug: Disitamab VedotinParticipants will receive a single postoperative intravesical instillation of 180mg disitamab vedotin within 96 hours after radical nephroureterectomy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Histologically or radiologically suspected UTUC planned for RNU
- HER2-positive tumor defined as IHC 1+, 2+, or 3+ on preoperative or surgical specimen testing.
- ECOG performance status 0-1.
- No prior or concomitant bladder urothelial carcinoma within 5 years.
Key exclusion criteria (2 listed)
- 1.Evidence of metastatic disease before enrollment. 2.Prior treatment with disitamab vedotin. 3.Prior intravesical anti-cancer therapy within 12 months. 4.Active uncontrolled infection. 5.Pregnancy or breastfeeding. 6.Severe uncontrolled cardiovascular, pulmonary, hepatic, or systemic disease. 7.Known hypersensitivity to study drug components. 8.Any condition that, in the investigator's judgment, would compromise participation or interpretation.
- -
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 |
|---|---|---|
| Drug: Disitamab VedotinParticipants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy. | Drug | Intravesical Disitamab Vedotin Participants will receive a single postoperative intravesical instill |
Primary outcome
12-Month Intravesical Recurrence Rate
Time frame: 12 months
Proportion of participants with histologically confirmed bladder urothelial recurrence within 12 months after radical nephroureterectomy.
5 secondary outcomes
Intravesical Recurrence-Free Survival (IVRFS)
Time frame: Up to 24 months
Cumulative Incidence of Bladder Recurrence
Time frame: 12 months, 24 months
Metastasis-Free Survival (MFS)
Time frame: Up to 24 months
Safety and Tolerability
Time frame: From treatment to 90 days after instillation
Feasibility of Intravesical RC48 Administration
Time frame: Day 1
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 18 May 2026.
- Individual participant dataSharing planned: No
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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.
wei xue, M.D principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: Disitamab Vedotin in people with Upper Urinary Tract Urothelial Carcinoma, run by RenJi Hospital 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 8 inclusion and 2 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 18 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 jiwei h jiwei huang (8613651682825, jiweihuang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Month Intravesical Recurrence Rate (time frame: 12 months). 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 18 May 2026.