NCT07646145 Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
| NCT ID | NCT07646145 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanxi Province Cancer Hospital |
| Condition | Non-Muscle-Invasive Bladder Cancer (NMIBC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-04-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07646145 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Muscle-Invasive Bladder Cancer (NMIBC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07646145 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07646145 currently recruiting?
Yes, NCT07646145 is actively recruiting participants. Contact the research team at hanxuebing808@126.com for enrollment information.
Where is the NCT07646145 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT07646145 clinical trial?
NCT07646145 is sponsored by Shanxi Province Cancer Hospital. The trial plans to enroll 30 participants.
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