Disitamab Vedotin plus Mitomycin C for HER2-positive high-risk NMIBC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating the safety and effectiveness of intravenous disitamab vedotin combined with intravesical mitomycin C in adults with HER2-expressing intermediate- to high-risk non-muscle-invasive bladder cancer who have completed TURBT and show no obvious residual disease. The goal is to see if this combination can reduce tumor recurrence, lower the need for radical bladder surgery, and improve quality of life. Eligible participants must have tissue-confirmed NMIBC, be intolerant or non-responsive to BCG, and provide tumor samples for HER2 assessment. The study is sponsored by Shanxi Province Cancer Hospital and is conducted at Shanxi Provincial Cancer Hospital in Taiyuan, China.

Why it matters

Who can join: the full rules

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)

Where it's running

• Shanxi Provincial Cancer Hospital
  Taiyuan, Shanxi, China Recruiting

Study contacts

• Study coordinator: Xuebing Han
• Email: hanxuebing808@126.com
• Phone: 86+17861282270

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.