Bladder Cancer
Conditions
Interventions
Tislelizumab combined with gemcitabine and cisplatin:Tislelizumab combined with gemcitabine and cisplatin
Sponsors
Army Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent; 2. Ability to comply with the protocol; 3. Aged >= 18 years; 4. Suitable and planned for radical cystectomy; 5. Histopathological result confirmed urotherlial carcinoma or a dominant urothelial carcinoma (i.e. 50% at least); 6. Clinical stage is T2-T4aN0M0 revealed by CT (or MRI). If the clinical stage is T2-4aN1-3M0 and the investigator judged that radical surgery can still be performed, the patient can be included in the study; 7. Expected survival time is greater than 1 year; 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0/1; 9. Agree to provide tissue examination specimens for PD-L1 detection, genetic sequencing, transcriptional sequencing or single cell sequencing; 10. The organ function level must meet the following requirements: (1) Hematological indicators: absolute neutrophil count >= 1.5x10^9/L, platelet count >= 80x10^9/L, hemoglobin >= 6.0 g/dL; (2) Liver function: total bilirubin = 30 ml/min.
Exclusion criteria
Exclusion criteria: 1. Receive live attenuated vaccines or immunosuppressive drugs within 4 weeks before treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (prednisolone or equivalent physiological doses of no more than 10 mg/day), or plan to receive live attenuated vaccines during the study period; 2. Have a clear history of primary immunodeficiency, active, known or suspected autoimmune diseases, allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 3. Female patients who are pregnant or breastfeeding, reproductive men or women who are likely to become pregnant have not taken reliable contraceptive measures; 4. Active tuberculosis,untreated acute or chronic active hepatitis B or C infection, the investigator will judge whether they are eligible for enrollment for the patients receiving antiviral therapy, according to the individual conditions of the patient while monitoring the virus copy number; 5. Uncontrolled concurrent diseases: HIV-infected persons, poorly controlled serious infections, uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases); 6. Those who are participating in other clinical research, or have previously received PD-1/PD-L1/CTLA-4 antibody or other immunotherapy; 7. Those who are suspected to be allergic to tislelizumab, gemcitabine and cisplatin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response;disease-free survival for 2 years;Overall survival for 2 years; | — |
Countries
China
Contacts
Public ContactJun Jiang
Daping Hospital, Army Medical University
Outcome results
None listed