Non-Muscle-Invasive Bladder Cancer (NMIBC)Phase 2NCT07646145
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
A Phase 2 study testing Disitamab Vedotin and Mitomycin C (MMC) in people with Non-Muscle-Invasive Bladder Cancer (NMIBC), run by Shanxi Province Cancer Hospital at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle-Invasive Bladder Cancer (NMIBC)
- What is being tested?
- Disitamab Vedotin and Mitomycin C (MMC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to Apr 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation, signing a written informed consent form;
- The age on the date of signing the informed consent form should be no less than 18 years old, regardless of gender;
- The subjects have completed the standard TURBT procedure before signing the informed consent form, and no obvious residual tumor lesions were found in the surgical field;
- The postoperative pathology clearly diagnosed as non-muscle-invasive bladder cancer, and the main tissue component was more than 50% urothelial carcinoma (transitional cell carcinoma);
- The subjects were classified into the intermediate-risk or high-risk group according to the risk classification for NMIBC;
- Tumor tissue samples for TURBT must be provided, along with the required relevant pathological reports. Fresh surgical tissues or pathological slides can be sent for examination as well;
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- The patients were intolerant to BCG or did not accept the BCG infusion treatment plan;
- Before treatment, HER2 detection was conducted on the resection specimens in the laboratory: The IHC results confirmed HER2 expression (defined as: IHC 1+, 2+ or 3+);
- Clinical non-metastatic bladder cancer (N0, M0) was determined by abdominal computed tomography (CT).
Who cannot join
- History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;
- Imaging results within 3 months before treatment indicated lymph node or other site/organ metastasis;
- Imaging results within 3 months before treatment indicated the presence of other urinary system tumors;
- Received other systemic anti-cancer treatments within 3 weeks before treatment, including chemotherapy, biological therapy, immunotherapy, targeted therapy, endocrine therapy, and/or investigational drug therapy;
- Received bladder radiotherapy for urothelial carcinoma before treatment;
- Known to have anaphylaxis or delayed allergic reaction to certain components of vedacitinib or similar drugs;
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- Within the 3 days prior to the first infusion, the following conditions had not yet been alleviated to CTCAE grade 1:Uncontrolled acute or chronic infections, such as pneumonia, biliary tract infections;Hepatitis B and Hepatitis C infections; dyspnea;Acute or chronic kidney injury; nephrotic syndrome; bladder perforation; urinary tract obstruction;
- NYHA rating of 3 or 4;
- Symptoms and signs related to cardiovascular diseases: including myocardial infarction, congestive heart failure, arrhythmia, etc.;
- Known cerebrovascular accidents;
- History of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, hemolytic anemia, rheumatoid arthritis, etc.);
- Known positive HIV serology, Hepatitis C infection and/or Hepatitis B (HepBsAg or core antibody positive and responding after antiviral treatment for Hepatitis B, except for these patients: these patients are allowed to participate in this study; Note: Patients with negative HepBsAg at screening)
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
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000
Xuebing Han, 86+17861282270, hanxuebing808@126.com
About this study
Official title: Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Medium-high Risk Non-Muscle-Invasive Bladder Cancer: A Phase II Clinical Trial
This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. The goal is to provide a new treatment option for NMIBC patients, reduce the risk of tumor recurrence, decrease the proportion of radical bladder surgery, and improve the quality of life of patients.
- Being tested
- Disitamab Vedotin, Mitomycin C (MMC)
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab VedotinDrug
Disitamab Vedotin injection: 2.0 mg/kg, every two weeks, treatment lasts for 8 to 12 cycles
Mitomycin C (MMC)Drug
Mitomycin bladder intravesical instillation: 40mg per dose. Instill immediately after surgery, then once a week thereafter. The induction chemotherapy instillation lasts for 8 times. Subsequently, it is instilled once a month for a total of 10 months for maintenance chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin Plus Intravesical Mitomycin C | Experimental | Participants will receive intravenous disitamab vedotin in combination with intravesical mitomycin C according to the protocol-defined treatment schedule. Receives: Drug: Disitamab Vedotin; Drug: Mitomycin C (MMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year disease-free survival rate(1-year DFS rate)
defined as the time from study treatment initiation to disease recurrence (confirmed by cystoscopic biopsy or imaging), disease progression (muscle invasion or distant metastasis), or death from any cause, estimated by the Kaplan-Meier method.
Measured: At 12 months after the first study treatment.
Secondary outcomes (3)
Disease-free survival
Disease-free survival is defined as the time from the date of first study treatment to the first documented recurrence, disease progression, death from any cause, or last disease assessment, whichever occurred first.
Measured: From drug combination to the first documented recurrence, disease progression, death from any cause, or last follow-up, assessed up to 12 months.
Overall Survival（OS）
Overall survival is defined as the time from the date of first study treatment to death from any cause. Participants who are alive at the last follow-up will be censored at the date of last known follow-up.
Measured: From the date of first study treatment to the date of death from any cause or last known follow-up, whichever occurred first, assessed up to 12 months.
Incidence and Severity of Treatment-emergent Adverse Events
Treatment-emergent adverse events are defined as adverse events that occur or worsen after initiation of study treatment. Adverse events will be recorded and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: From the date of first study treatment until 30 days after the last dose of study treatment, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Apr 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle-Invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Province Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanxuebin, Shanxi Province Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646145
- Sponsor's protocol ID
- KY2024066
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Medium-high Risk Non-Muscle-Invasive Bladder Cancer: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07646145
- Acronym / sponsor ID
- KY2024066
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanxi Province Cancer HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Jun 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 study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. The goal is to provide a new treatment option for NMIBC patients, reduce the risk of tumor recurrence, decrease the proportion of radical bladder surgery, and improve the quality of life of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin Plus Intravesical Mitomycin C | Experimental | Drug: Disitamab Vedotin, Drug: Mitomycin C (MMC)Participants will receive intravenous disitamab vedotin in combination with intravesical mitomycin C according to the protocol-defined treatment schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary participation, signing a written informed consent form;
- The age on the date of signing the informed consent form should be no less than 18 years old, regardless of gender;
- The subjects have completed the standard TURBT procedure before signing the informed consent form, and no obvious residual tumor lesions were found in the surgical field;
- The postoperative pathology clearly diagnosed as non-muscle-invasive bladder cancer, and the main tissue component was more than 50% urothelial carcinoma (transitional cell carcinoma);
- The subjects were classified into the intermediate-risk or high-risk group according to the risk classification for NMIBC;
Key exclusion criteria (12 listed)
- History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;
- Imaging results within 3 months before treatment indicated lymph node or other site/organ metastasis;
- Imaging results within 3 months before treatment indicated the presence of other urinary system tumors;
- Received other systemic anti-cancer treatments within 3 weeks before treatment, including chemotherapy, biological therapy, immunotherapy, targeted therapy, endocrine therapy, and/or investigational drug therapy;
- Received bladder radiotherapy for urothelial carcinoma before treatment;
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 |
|---|---|---|
| Disitamab VedotinDisitamab Vedotin injection: 2.0 mg/kg, every two weeks, treatment lasts for 8 to 12 cycles | Drug | Disitamab Vedotin Plus Intravesical Mitomycin C |
| Mitomycin C (MMC)Mitomycin bladder intravesical instillation: 40mg per dose. Instill immediately after surgery, then once a week thereafter. The induction chemotherapy instillation lasts for 8 times. Subsequently, it is instilled once a month for a total of 10 months for maintenance chemotherapy. | Drug | Disitamab Vedotin Plus Intravesical Mitomycin C |
Primary outcome
1-year disease-free survival rate(1-year DFS rate)
Time frame: At 12 months after the first study treatment.
defined as the time from study treatment initiation to disease recurrence (confirmed by cystoscopic biopsy or imaging), disease progression (muscle invasion or distant metastasis), or death from any cause, estimated by the Kaplan-Meier method.
3 secondary outcomes
Disease-free survival
Time frame: From drug combination to the first documented recurrence, disease progression, death from any cause, or last follow-up, assessed up to 12 months.
Overall Survival（OS）
Time frame: From the date of first study treatment to the date of death from any cause or last known follow-up, whichever occurred first, assessed up to 12 months.
Incidence and Severity of Treatment-emergent Adverse Events
Time frame: From the date of first study treatment until 30 days after the last dose of study treatment, assessed up to 12 months.
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 12 Jun 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.
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 Disitamab Vedotin and Mitomycin C (MMC) in people with Non-Muscle-Invasive Bladder Cancer (NMIBC), run by Shanxi Province Cancer 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 9 inclusion and 12 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 12 Jun 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 Xuebing Han (86+17861282270, hanxuebing808@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year disease-free survival rate(1-year DFS rate) (time frame: At 12 months after the first study treatment.). 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 12 Jun 2026.