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.
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);
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;
Single group
Disitamab Vedotin
DrugDisitamab Vedotin injection: 2.0 mg/kg, every two weeks, treatment lasts for 8 to 12 cycles
Mitomycin C (MMC)
DrugMitomycin 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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
