muscle-invasive urothelial carcinoma of the bladder
Conditions
Interventions
control group:Toripalimab
experimental group:Disitamab Vedotin + Toripalimab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical study; fully understand and be informed of this study and sign the Informed Consent Form (ICF); be willing to follow and capable of completing all trial procedures. 2. Age >= 18 years at the time of signing the ICF. 3. Patients with histopathologically confirmed muscle-invasive urothelial carcinoma of the bladder who underwent radical cystectomy and bilateral pelvic lymph node dissection (with the number of harvested lymph nodes =10). Postoperative pathology confirmed the pathological stage as pT3b-4NanyM0, pTanyN+M0, or urothelial carcinoma patients with high-risk of progression, including those with poor downstaging after platinum-based neoadjuvant therapy (ypT2-4/ypN+), according to the 8th edition of the AJCC TNM Staging System for Bladder Cancer. 4. Patients who did not receive platinum-based neoadjuvant chemotherapy refused platinum-based chemotherapy or were intolerant to platinum-based adjuvant chemotherapy after RC (according to EORTC criteria): WHO or ECOG PS of 2, or Karnofsky PS of 60%-70% Creatinine clearance rate =2 hearing loss CTCAE grade >=2 peripheral neuropathy Elderly patients with severe cardiovascular and cerebrovascular underlying diseases Patients with New York Heart Association (NYHA) functional classification =1 year. 9. Organ and hematopoietic functions must meet the following requirements: Hemoglobin (HGB) >=90 g/L White blood cell count (WBC) >=3×10?/L Absolute neutrophil count (ANC) >=1.5×10?/L Platelet count (PLT) >=80×10?/L Total bilirubin (TBIL) <=1.5× upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5×ULN Serum creatinine (Cr) <=2.5×ULN; or creatinine clearance rate (CCr) =30 ml/min. 10. Female subjects of childbearing potential must agree to take effective contraceptive measures after signing the ICF, during the study, and for 6 months after the last dose of Vidicitumab. Females of childbearing potential must have a negative serum pregnancy test within 7 days before trial screening. Any male or female patient of childbearing potential must agree to use effective contraception throughout the trial and for 6 months after the trial ends. For the purpose of this study, a patient is considered to be of childbearing potential if they are biologically capable of having children and have normal sexual activity, as determined by the investigator.
Exclusion criteria
Exclusion criteria: 1. Patients with upper urinary tract tumors at the time of diagnosis; 2. Tumor pathology is pure bladder squamous cell carcinoma, pure bladder adenocarcinoma, pure bladder sarcoma, pure bladder small cell carcinoma, or urothelial carcinoma combined with neuroendocrine differentiation; 3. M1 stage disease: presence of distant lymph node metastasis (abdominal aortic bifurcation/inguinal lymph nodes or beyond) or distant organ metastasis; 4. Patients who underwent bilateral pelvic lymph node dissection with a total number of lymph nodes dissected <10; 5. Patients with negative HER2 immunohistochemical expression (IHC: 0); 6. Patients who have previously received HER2-targeted therapy for bladder cancer (such as DS8201, etc.); 7. Patients currently participating in other clinical studies related to unapproved drugs for bladder cancer; 8. Pregnant or lactating women; 9. Patients with severe medical conditions, such as severe infections, uncontrolled diabetes, cardiovascular diseases (New York Heart Association class III or IV heart failure, grade II or higher atrioventricular block, myocardial infarction within the past 1 month, unstable arrhythmia or unstable angina, cerebral infarction within 1 month, etc.), severe pulmonary diseases (interstitial pneumonia, severe obstructive pulmonary disease, history of symptomatic bronchospasm), or clinical symptoms of liver, kidney, hematological endocrine system, or neuropsychiatric diseases; 10. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first drug administration in the study(Use of physiological doses of glucocorticoids (=10 mg/day prednisone or equivalent) is permitted); 11. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV1/2 antibodies); 12. Untreated active hepatitis B; however, hepatitis B subjects meeting the following criteria are also eligible (HBV viral load must be <1000 copies/ml (200 IU/ml) before the first drug administration, and subjects should receive anti-HBV therapy throughout the study's chemotherapy period to prevent viral reactivation. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is needed); 13. Subjects with active HCV infection (positive HCV antibody and HCV-RNA level above the detection limit); 14. Vaccination with live vaccines within 30 days before the first drug administration (Cycle 1, Day 1) (Note: Administration of injectable inactivated viral vaccines for seasonal influenza within 30 days before the first drug administration is permitted, but live attenuated influenza vaccines administered intranasally are not permitted); 15. Concomitant active cancer, or history of other malignant tumors within the past five years, except: (1) cured cutaneous non-melanoma skin cancer; (2) cured tumors including cervical in-situ carcinoma, superficial bladder cancer; (3) other solid tumors that have received radical treatment with no recurrence or metastasis for 5 years or more; 16. Previous history of confirmed neurological or psychiatric disorders, such as epilepsy, dementia, or poor compliance; 17. History of drug abuse or substance misuse; 18. Other severe, acute, or chronic diseases or laboratory test abnormalities that may increase the risk of participating in the study and study medication, or may interfere w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years Disease-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;2 years Metastasis-Free Survival;2 years Local Recurrence-Free Survival;Overall survival; | — |
Countries
China
Contacts
Public ContactKai Yao
Sun Yat-sen University Cancer Center
Outcome results
None listed