Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer

June 9, 2026 updated by: hanxuebin, Shanxi Province Cancer Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;
  • 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).

Exclusion Criteria:

  • 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;
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Disitamab Vedotin Plus Intravesical Mitomycin C
Participants will receive intravenous disitamab vedotin in combination with intravesical mitomycin C according to the protocol-defined treatment schedule.
Drug: Disitamab Vedotin
Disitamab Vedotin injection: 2.0 mg/kg, every two weeks, treatment lasts for 8 to 12 cycles
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 months after the first study treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
From the date of first study treatment until 30 days after the last dose of study treatment, assessed up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanxi Province Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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