Her2 high expression high-risk Non-muscle-invasive Bladder Cancer
Conditions
Interventions
Combination Therapy Group(Experimental Group):Bacillus Calmette-Guérin (BCG) intravesical perfusion combined with intravenous injection of Disitamab Vedotin (2.0 mg/kg, Q2W, 8 cycles)
Standard Treatment Group:Bacillus Calmette-Guérin (BCG) intravesical perfusion
Sponsors
Sun Yat-sen University Cancer Center (Sun Yat-Sen University Cancer Center, Sun Yat-sen University Cancer Institute)
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; be willing to comply with and capable of completing all trial procedures; 2.Age >= 18 years old, regardless of gender; 3.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score = 2 years; 5.Histopathologically confirmed non-muscle-invasive urothelial carcinoma of the bladder (in accordance with the 8th Edition of the International TNM Staging System for Bladder Cancer); stratified as high-risk or very high-risk according to the 2024 European Association of Urology (EAU) Guidelines; histologic type is predominantly urothelial carcinoma (urothelial carcinoma component should be > 50%), and subjects with small cell carcinoma component or neuroendocrine differentiation are not eligible for enrollment; 6.All patients have undergone transurethral resection of bladder tumor (TURBT) with R0 resection achieved (no residual carcinoma identified in postoperative pathology and no carcinoma detected in the bladder muscularis propria); the interval between the last transurethral resection and the first administration of study treatment should be less than 2 months; 7.Immunohistochemical staining of bladder tumor specimens indicates HER2 2+/3+ (interpreted in accordance with the Chinese Expert Consensus on Clinical Pathological Detection of Human Epidermal Growth Factor Receptor 2 in Urothelial Carcinoma) (results of HER2 fluorescence in situ hybridization (FISH) detection are not regarded as enrollment criteria); 8.Organ function and hematopoietic function must meet the following requirements: Hemoglobin (HGB) >= 70 g/L; White Blood Cell (WBC) count >= 3×10^9/L; Absolute Neutrophil Count (ANC) >= 1.5×10^9/L; Platelet (PLT) count >= 80×10^9/L; Total Bilirubin (TBIL) = 50 mL/min; International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5×ULN; 9.Female subjects of childbearing potential must agree to adopt effective contraceptive measures after signing the informed consent form, during the study period, and within 6 months after the last administration of Disitamab Vedotin.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of intravesical perfusion therapy with Bacillus Calmette-Guérin (BCG); 2.Patients with a confirmed medical history of muscle-invasive bladder cancer (>= T2), or with lymph node metastasis or distant metastasis; 3.Patients who have received neoadjuvant or adjuvant radiotherapy and chemotherapy for bladder cancer in the past; 4.Patients with a prior history of HER2-targeted therapy; or patients with bladder tumor pathologically confirmed as pure squamous cell carcinoma of the bladder, adenocarcinoma, bladder sarcoma, small cell carcinoma of the bladder, or bladder endocrine tumor; 5.Patients complicated with upper urinary tract tumor or urethral tumor (including prostatic urothelial carcinoma); 6.Patients who have received other anti-tumor therapies (including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, monoclonal antibody therapy) within 4 weeks before the initiation of study treatment, or have participated in clinical trials of other unapproved drugs; 7.Pregnant or lactating women; 8.Patients with severe internal diseases, such as severe infection, uncontrolled diabetes mellitus, cardiovascular diseases (New York Heart Association (NYHA) class ? or ? heart failure, atrioventricular block of degree ? or above, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, etc.) or pulmonary diseases (history of interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm); 9.Patients with a definite history of neurological or mental disorders (e.g., epilepsy, dementia) or poor compliance; 10.Patients with a history of drug abuse or addiction; 11.Patients diagnosed with immunodeficiency, or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of study treatment; the use of physiological doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent drugs) is permitted; 12.Patients with a known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV1/2 antibodies); 13.Patients with other severe, acute or chronic diseases or abnormal laboratory test results that may increase the risk of study participation and study drug administration, or may interfere with the interpretation of study results; 14.Patients who are deemed unsuitable for study participation by the investigators due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years event free survival rate(2y- EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (Only for those with CIS), DOR;2-year disease-specific survival rate, 2y-CSS;Complete remission rate (only for those with CIS), CR;The 2-year recurrence-free survival rate, 2y-RFS;Safety;2-year progression-free survival, 2y-PFS;Quality of life, QoL; | — |
Countries
China
Contacts
Public ContactKai Yao
Sun Yat-sen University Cancer Center (Sun Yat-Sen University Cancer Center, Sun Yat-sen University Cancer Institute)
Outcome results
None listed