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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanxi Province Cancer Hospital

About this 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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Disitamab Vedotin
  • Mitomycin C (MMC)

Treatment groups

30 Participants
are divided into 1 treatment group