Bladder Cancer
Conditions
Interventions
experimental group:Toripalimab combined with GC chemotherapy
Sponsors
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with MIBC are preparing for radical cystectomy; 2. Aged 18 to 80 years; 3. The clinical stage of the tumor is (c) T2-3bN0M0; 4. ECOG score = 90g/L. Neutrophils >= 1.5*10^9/L; Platelet count >= 100*10^9/L; serum potassium 3.5 to 5.5mmol/L; Liver function indicators: ALT, AST=60mL/min; Left ventricular ejection fraction (LVEF) >= 50%; 7. Subjects participate voluntarily, and the subjects themselves must sign an informed consent (ICF), indicating that they understand the purpose and required procedures of this research and are willing to participate in the research. Subject must be willing and aware of and comply with the prohibitions and restrictions specified in the research protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who cannot tolerate radical cystectomy. 2. Patients with MIBC with distant metastasis (abdominal CT plain scan + enhanced, chest CT plain scan, ECT-bone scan, PET-CT, MRI, etc.). 3. There are complications that are difficult to control, including but not limited to persistent infection, symptomatic congestion Heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung illness, severe chronic gastrointestinal disease related to diarrhea, or mental illness/social conditions, which will restrict its compliance with research requirements, greatly increase the risk of causing AEs or Impair the patient's ability to give written informed consent. 4. Patients with allergies or hypersensitivity to treatment drugs, patients with autoimmune diseases 5. Previous exposure to systemic immunotherapy, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2 antibodies. 6. He had received live attenuated vaccines or had serious infections one month before enrollment. 7. Patients were treated with systemic corticosteroids or other systemic immunosuppressive drugs within 2 weeks before enrollment or were expected to require systemic immunosuppressive drugs during the trial period. 7,Active or symptomatic viral hepatitis or other chronic liver diseases, known infections Human immunodeficiency virus (HIV). (9) Active tuberculosis. (10) Other situations where the researcher thinks it is inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR;progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| overal survival, OS; | — |
Countries
China
Contacts
Public ContactGuo Hongqian
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Outcome results
None listed