muscle-invasive bladder cancer
Conditions
Interventions
bladder-conserving comprehensive treatment for muscle-invasive bladder cancer:NA
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) Primary MIBC with histological or cytological confirmation, cT2-3bN0M0 (2) The histological type was urothelial carcinoma (3) : Single focal tumor (4) : No hydronephrosis (5) : No CIS (6) : Physical status with ECOG score =1 (7) : No other treatment (8) : It is not suitable for radical bladder resection or has a strong desire to preserve the bladder (9) : Age =18 years old (10) : Sign informed consent (11) : Having good organ function, as described below: : Absolute neutrophil count =1500 /µL; : Platelet =100000/µL; : Hemoglobin =90g/L; : Serum creatinine =1.5 x upper limit of normal (ULN) or calculated creatinine clearance = 30 mL/min; : aspartate aminotransferase and alanine aminotransferase = 1.5 x ULN; : albumin =2.5mg/dL; : The coagulation index is normal
Exclusion criteria
Exclusion criteria: (1) : History of severe hypersensitivity to humanized monoclonal antibodies (2) : Prior treatment for PD-1 / PD-L1 (3) : Participants with an active autoimmune disease or a history of autoimmune disease that may recur (4) : A known history of severe cardiovascular disease and human immunodeficiency virus (HIV) (5) : renal function, bone marrow insufficiency (6) : Other malignancies have been active within 3 years (7) : Patients with a previous history of radiation therapy and/or radiotherapy-related adverse reactions (8) : Any serious or uncontrolled physical disease, as assessed by the investigator, that will lead to serious consequences during treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year bladder-conserving survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS);security;Progression free survival(PFS);Response rate to neoadjuvant therapy; | — |
Countries
China
Contacts
Public ContactWang Zhiping
Lanzhou University Second Hospital
Outcome results
None listed