Invasive bladder cancer
Conditions
Interventions
Experimental group:Vedolizumab
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 years or older; 2. Patients diagnosed with HER-2 expression (HER-2 immunohistochemistry results of 1, 2, or 3) high-risk non–muscle-invasive bladder cancer; 3. Histopathologically confirmed high-risk non–muscle-invasive bladder cancer or predominantly high-risk non–muscle-invasive bladder cancer (>50% of pathology), defined as follows: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS); d. Multiple tumors, tumor diameter >3 cm, or recurrent tumor; 4. Multiple mucosal biopsies showing >2 areas and >3 pathological sites with the above histopathological diagnosis; 5. Agree to provide blood, urine, and tissue samples (for testing immunohistochemistry, tumor mutation burden, DNA and RNA analysis, etc.); 6. Organ function must meet or, under supportive treatment, meet the following requirements: a. Hematologic indicators: absolute neutrophil count >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=9.0 g/dL; b. Liver function: total bilirubin =50 mL/min (Cockcroft-Gault formula); 7. The subject voluntarily joins the study, signs the informed consent form, complies well, and cooperates with follow-up.
Exclusion criteria
Exclusion criteria: 1. The tumor pathology is simple bladder squamous cell carcinoma, simple bladder adenocarcinoma, simple bladder sarcoma, simple bladder small cell carcinoma, or urothelial carcinoma with neuroendocrine differentiation; 2. Receive attenuated live vaccine within 4 weeks before enrollment or plan to receive it during the study period. Active, known or suspected autoimmune diseases; 3. Known history of primary immunodeficiency; 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 5. Pregnant or lactating female patients; 6. Untreated individuals with acute or chronic active hepatitis B or C infection. Patients undergoing antiviral therapy will be monitored for virus copy number, and doctors will determine whether they are eligible for enrollment based on their individual circumstances; 7. Have used immunosuppressive drugs within 4 weeks before starting treatment, excluding nasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e. not exceeding 10mg/day of prednisolone or other corticosteroids at physiological doses of equivalent drugs); 8. Known or suspected allergy to chemotherapy or vediximab; 9. Have a clear history of active tuberculosis; 10. Currently participating in other clinical researchers; 11. Men with reproductive ability or women with the possibility of pregnancy have not taken reliable contraceptive measures; 12. Uncontrolled concurrent diseases, including but not limited to: a. HIV infected individuals (HIV antibody positive). b. Severe infections that are active or poorly controlled clinically. c. Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]). d. Individuals with active bleeding or newly developed thrombotic disease who are taking therapeutic doses of anticoagulant drugs or have a tendency to bleed (excluding those whose symptoms can be controlled through supportive therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| The pathological downstaging rate after re-TURBT or radical cystectomy;Duration of Response;The incidence of adverse events and serious adverse events;Cystectomy-Free Survival;Time to radical cystectomy;Overall survival time; | — |
Countries
China
Contacts
Public ContactChunhua Lin
Yantai Yuhuangding Hospital
Outcome results
None listed