Bladder Cancer
Conditions
Interventions
Experimental group:BCG intravesical instillation (1 year, 19 times) + Disitamab vedotin (2.0mg/kg, iv, Q2W, 8cycle)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the clinical study; fully understand and be informed about the study and sign the informed consent form; be willing to follow and have the ability to complete all trial procedures; 2. Age 18-80; 3. Confirmed by histopathology as non muscle invasive bladder urothelial carcinoma (according to the International TNM Staging Standard for bladder cancer, 8th Edition); If there are rare pathological types such as squamous epithelial differentiation, adenoid differentiation, microemulsification, small cell carcinoma, neuroendocrine carcinoma, clear cell carcinoma, sarcoma, etc., they will not be included in the group; 4. All patients have undergone TURBT and achieved R0 resection (No residual cancer was found in postoperative pathology, and no cancer was found in the bladder muscle layer), and the interval between surgery and the first dose of disitamab vedotin should be less than 2 months; 5. HER2 immunohistochemical staining of bladder cancer was 2+/3+ (According to the consensus of clinical and pathological experts on the detection of human epidermal growth factor receptor 2 in Chinese urothelial carcinoma). 6. ECOG status: 0-1. 7. Estimated survival time = one year; 8. Organ function and hematopoietic function must meet the following requirements: HGB=70g/L; WBC= 3×10^9/L; ANC= 1.5×10^9/L; PLT=80×10^9/L; TBIL=1.5×ULN; AST, ALT=2.5×ULN; Cr= 1.5×ULN or CrCl =50mL/min; INR or PT=1.5×ULN; 9. Female participants of childbearing age must agree to take effective contraceptive measures within six months after signing the informed consent form, during the study period, and after the last dose of vidiximab. Women with fertility must have a negative blood pregnancy test within 7 days prior to trial screening; Any male or female patient with fertility must agree to use effective contraceptive methods throughout the entire trial period and within six months after the end of the trial. According to the researcher's judgment, a patient's fertility refers to their biological ability to have children and have normal sexual activity.
Exclusion criteria
Exclusion criteria: 1. Patients have received prior intravesical instillation of BCG; 2. Pathologically confirmed muscle invasive bladder cancer (=pT2) or presence of lymph node metastasis or distant metastasis; 3. Patients have received neoadjuvant or adjuvant radiotherapy or chemotherapy for bladder cancer; 4. Patients have previously used HER2-targeted therapy; 5. Bladder tumors combined with squamous epithelial differentiation, adenoidal differentiation, micropapillary differentiation, small cell carcinoma, neuroendocrine carcinoma, clear cell carcinoma, sarcoma, and other rare pathological types; 6. Patients received other anti-tumor treatments (including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, monoclonal antibody therapy) within 4 weeks prior to the start of the study treatment, or those who are involved in other clinical studies; 7. Pregnant or lactating women; 8. Those with severe medical conditions such as severe infections, uncontrolled diabetes mellitus, cardiovascular disease (Grade III or IV heart failure defined by the New York Heart Association classification, Grade II or above heart conduction block, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.), or pulmonary disease (interstitial pneumonia, obstructive lung disease, and history of symptomatic bronchospasm); 9. Those with a previous history of definite neurological or psychiatric disorders, such as epilepsy, dementia, and poor compliance; 10. History of drug or substance abuse; 11. Patients with severe, acute, or chronic medical conditions or abnormal laboratory tests that may increase the risk of participation in the study and study medication, or that may interfere with the interpretation of the study results 12. The researchers believe that due to other reasons, they are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year rucurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year rucurrence-free survival;Progression-free survival;Bladder preservation rates;OS; | — |
Countries
China
Contacts
Public ContactKai Yao
Department of Urology, Sun Yat-sen University Cancer Center
Outcome results
None listed