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New treatment option for Non-Muscle-Invasive Bladder Cancer (NMIBC)
Official title Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT07646145
What this study is testing
What is Disitamab Vedotin?
Disitamab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-muscle-invasive bladder cancer (nmibc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 people have completed the standard TURBT procedure before signing the informed consent form, and no obvious residual tumor lesions were found in...
- The postoperative pathology clearly diagnosed as non-muscle-invasive bladder cancer, and the main tissue component was more than 50% urothelial...
- The people were classified into the intermediate-risk or high-risk group according to the risk classification for NMIBC;
You likely can't join if
- History of muscle-invasive bladder cancer or metastatic bladder cancer before treatment;History of muscle-invasive bladder cancer or metastatic...
- 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...
- Received bladder radiotherapy for urothelial carcinoma before treatment;
- Known to have anaphylaxis or delayed allergic reaction to certain components of vedacitinib or similar drugs;
See the full eligibility 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 people 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 people 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).
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Taiyuan, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiyuan, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.