Bladder cancer
Conditions
Interventions
Experimental Group A:Neoadjuvant Chemotherapy, PD-1 and Radical nephroureterectomy and Retroperitoneal lymph node dissection
Experimental Group B:Neoadjuvant Chemotherapy, Radical nephroureterectomy and Retroperitoneal lymph node dissection
Controlled Group:Radical nephroureterectomy and Retroperitoneal lymph node dissection
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in this study and sign an informed consent form; 2. Male or female, aged >= 18 years (including cut-off value) and = 6 months; 4. Urinary urothelial carcinoma diagnosed by histopathology, or mainly urothelial carcinoma with squamous epithelial or glandular epithelial metaplasia; 5. High grade upper urinary tract urothelial carcinoma diagnosed as T2-4 and N0-1 by ureteroscopy or urine shedding cytology, CT, MRI or PET-CT, etc., to exclude distant metastasis; 6. ECOG physical status: 0 or 1 point; 7. Sufficient heart, bone marrow, liver and kidney functions (subject to the normal value of the clinical trial center) Heart function: Heart function 0-2; Blood routine: WBC >= 3.5 x 10^9 / L, neutrophil absolute value >= 1.5 x 10^9 / L, PLT >= 75.0 x 10^9 / L, HGb>= 80g / L; Liver function: total bilirubin = 50ml / min; 8. Willing and able to follow the test and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. With bladder cancer or contralateral upper urinary tract tumor, a history of previous bladder cancer; 2. Severe cardiovascular diseases are known, including any of the following: Myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) occurred in the past year; severe / unstable angina; uncontrollable hypertension; heart rate Failure, reaching New York Heart Association (NYHA) level III or IV; ventricular arrhythmia requiring medical treatment; 3. Have a history of immunodeficiency (including HIV test positive, other acquired and congenital immunodeficiency diseases) or organ transplant history; 4. Have a history of severe central nervous system diseases. Have a history of epilepsy or any history that may induce epilepsy, including unexplained loss of consciousness or transient ischemic attack; 5. Combined with other malignant tumors in the past 5 years, except for cured basal cell carcinoma and cervical carcinoma in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year CSS;3-year OS;OR; | — |
Countries
China
Contacts
Public ContactZhuowei Liu
Sun Yat-Sen University Cancer Center
Outcome results
None listed