Urothelial Carcinoma
Conditions
Interventions
experimental group:Neoadjuvant therapy of tislelizumab combined with albumin paclitaxel
Sponsors
Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Radical cystectomy or radical transurethral resection is suitable and planned; 2. Male or female aged over 18 years; 3. Urothelial carcinoma or urothelial carcinoma as the main pathological component > 50%; 4. The clinical stage of T2-T4aN0M0 (CT / MRI + PET / CT), if the clinical stage is T2-4aN1-3M0, it needs to be judged by the researcher. If it is judged that radical surgery can still be performed, it can be included in the study; 5. The expected survival time was more than 12 weeks; 6. ECOG status score was 0-2; 7. Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc.); 8. Organ function level must meet the following requirements: (1) Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 80x10^9/L, hemoglobin >= 6.0 g/dl (can be maintained by blood transfusion); (2) Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=2.5 ULN; 9. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up.
Exclusion criteria
Exclusion criteria: 1. Receive live attenuated vaccine within 4 weeks before treatment or during the study period; 2. Active, known or suspected autoimmune diseases; 3. History of primary immunodeficiency; 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 5. Pregnant or lactating female patients; 6. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions; 7. Prior use of immunosuppressive drugs within 4 weeks prior to the start of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose); 8. Known or suspected allergy to tislelizumab and albumin paclitaxel; 9. Have a clear history of active tuberculosis; 10. Received PD-1 / PD-L1 / CTLA-4 antibody or other immunotherapy in the past; 11. Participating in other clinical researchers; 12. Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures; 13. Uncontrolled concurrent diseases, including but not limited to: 1) HIV infected (HIV antibody positive); 2) Severe infection in active stage or poorly controlled; 3) Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]); 4) Patients with active bleeding or new thrombotic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS;OS;Safety;SAE;irAE;Down stage<pT2 rate; | — |
Countries
China
Contacts
Public ContactHailong Hu
The Second Hospital of Tianjin Medical University
Outcome results
None listed