bladder urothelial carcinoma
Conditions
Interventions
Test group:GC+immunotherapy
Test group:GC
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The main pathological type after radical cystectomy was urothelial carcinoma (> 70%) with PT3-4A or PN+,M0; 2. Male or female aged 18-85 years; 3. The ECOG PS status score is 0-1; 4. Screening laboratory values must meet the following criteria: WBC > 2.0*10? / L, neutrophil > 1.0*10? / L, platelet > 100 *10? / L, hemoglobin > 90 g/ L; AST < 2.5 * ULN, ALT < 2.5 * ULN, bilirubin < 1.5 * ULN; (ULN: upper normal value); 5. GFR acuity 50 ml/min; 6. Able to comply with study and follow-up procedures; 7. Patients have the ability to understand and voluntarily sign the informed consent;
Exclusion criteria
Exclusion criteria: 1. Received live attenuated vaccine within 4 weeks before enrollment or planned during the study; 2. Active, known or suspected autoimmune diseases; 3. A known history of primary or secondary immunodeficiency; 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 5. Female patients planning pregnancy or breastfeeding; 6. Hearing loss > grade 2; 7. NYHA classification of heart failure > ?; 8. Peripheral neuropathy > grade 2; 9. A known history of human immunodeficiency virus, active tuberculosis, or other active infection that required treatment at the time of enrollment; 10. Hepatitis virus patients who test positive for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA) or are receiving antiviral therapy; 11. Medical conditions requiring the use of immunosuppressive agents, except for physiological doses of intranasal and inhaled corticosteroids or systemic corticosteroids, which do not exceed 10mg/day of prednisolone or its equivalent; 12. It is anticipated that major surgical procedures other than diagnostic procedures will be required during the study; 13. Severe infections within 2 weeks prior to study enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; 14. A previous or coexisting malignant tumor, the natural history or treatment of which may interfere; 15. The presence of severe or uncontrolled systemic disease;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival;safety evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;living quality; | — |
Countries
China
Contacts
Public ContactZhang Zhihong
The Second Hospital of Tianjin Medical University
Outcome results
None listed