Non-muscle invasive urothelial carcinoma of the bladder
Conditions
Interventions
Intervention group:Vedotinmab: 2.0mg/kg, ivd, d1, Q2W, 8cycles
For treatment, administer 120mg of BCG vaccine by intravesical perfusion, dissolve it in 40-50ml of normal saline, and administer intrave
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical study; fully understand and be informed of the study and sign the informed consent form; willing to follow and able to complete all trial procedures. 2. Age >=18 years, both genders. 3. ECOG PS score =2 years. 5. Histopathologically confirmed non-muscle invasive bladder urothelial carcinoma (according to the 8th edition of the International TNM Staging Standard for Bladder Cancer); classified as the very-high-risk subgroup according to the 2024 EAU guidelines for risk stratification of NMIBC. 6. Patients have undergone TURBT and achieved R0 resection (no residual tumor on postoperative pathology, and no cancer in the bladder muscle layer); the interval from the last TURBT to the first dose of the study drug should be less than 2 months. 7. Immunohistochemical staining of bladder tumor specimens shows HER2 1+ to 3+ (interpreted according to the Chinese Expert Consensus on HER2 Testing in Urothelial Carcinoma). 8. Patients refuse or are intolerant to radical cystectomy. 9. Organ function and hematopoietic function must meet the following requirements: Hemoglobin (HGB) >=70 g/L; White blood cell count (WBC) >=3×10^9/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=80×10^9/L; Total bilirubin (TBIL) =30 mL/min; International normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN. 10. Female subjects of childbearing potential must agree to use effective contraceptive measures from the time of signing the informed consent, during the study period, and within 6 months after the last dose of disitamab vedotin.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received intravesical instillation of bacillus Calmette-Guérin (BCG). 2. Patients with prior history confirmed as muscle-invasive bladder cancer (>=pT2) or with lymph node metastasis or distant metastasis. 3. Patients who have previously received adjuvant radiotherapy or chemotherapy for bladder cancer. 4. Patients who have previously received HER2-targeted therapy. 5. Patients with bladder tumor involving the prostatic urethra. 6. Patients with rare pathological types such as pure squamous cell carcinoma, adenocarcinoma, small cell carcinoma, neuroendocrine carcinoma, clear cell carcinoma, or sarcoma of the bladder are excluded. 7. Patients who have received other anti-tumor therapies (including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, or monoclonal antibody therapy) within 4 weeks before the start of study treatment, or who have participated in other clinical studies of unmarketed drugs. 8. Patients who are pregnant or breastfeeding. 9. Patients with severe medical diseases, such as severe infection, uncontrolled diabetes mellitus, cardiovascular disease (class III or IV heart failure defined by the New York Heart Association classification, second-degree or higher heart block, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, or cerebral infarction within the past 3 months), or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, or history of symptomatic bronchospasm). 10. Patients with a definite history of neurological or psychiatric disorders, such as epilepsy or dementia, or with poor compliance. 11. Patients with a history of drug abuse or substance abuse. 12. Patients with other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of participating in the study or taking the study drug, or that may interfere with the interpretation of study results. 13. Patients deemed unsuitable for participation in this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years Event-Free Survival (2y-EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Quality of Life;Treatment Emergent Adverse Event Rate;Overall Survival;2-year bladder preservation rate;2-year Progression-Free Survival(2y-PFS);2 years Recurrence-Free Survival (2y-RFS);Complete Response (CR);Adverse event; | — |
Countries
China
Contacts
Public ContactYao Kai
Sun Yat-sen University Cancer Center
Outcome results
None listed