muscle-invasive urothelial bladder cancer
Conditions
Interventions
treatment group:Toripalimab combined with chemotherapy for Neoadjuvant Treatment
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old of either gender. 2. Muscle-Invasive urothelial Bladder Cancer with a pre-treatment clinical stage of T2-4aN0-2M0. 3. Histologically confirmed muscle-invasive urothelial bladder cancer. 4. Fit and planned for cystectomy (according to surgeons evaluation). 5. Agreed to provide tissue samples for detection of PD-L1 expression, TMB and tumor infiltrating lymphocyte, etc.. 6. Adequate organ and hematologic functions. 7. Patients must not have had steroids for 4 weeks prior to study entry. 8. Male or female subjects of childbearing potential must be willing to use highly effective methods of birth control: oral contraceptives, intrauterine devices, controlled libido or barrier contraception combined with spermicide for the course of the study and through 12 months after the last dose of study medication. 9. Ability to understand the study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have been treated previously with Systematic anti-tumor therapy (including chemotherapy and immunotherapy, etc.) or radiotherapy for urothelial bladder carcinoma; Patients who have previously had diagnostic electrotomy and local cystectomy would be eligible. 2. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs; 3. Patients who have a preexisting or coexisting bleeding disorder; 4. Other uncontrollable inoperable patients; 5. A positive HIV test result; 6. Presence of active hepatitis B and hepatitis C (positive for HBsAg or HBcAband HBV DNA = 1000 IU/mL; positive for hepatitis C antibody and negative HCV-RNA levels is allowed); 7. A history of active tuberculosis; 8. Active autoimmune diseases required systematic therapy (Corticosteroids or immunosuppressive drugs) in the past 2 years; alternative therapies(thyroxine, insulin or Physical corticosteroid for renal or pituitary dysfunction) are allowed; 9. Other serious uncontrolled comorbidity that may affect patients compliance or interfere with the interpretation of results, including active infection, uncontrolled diabetes, cardiovascular disease (NHYA class III or IV heart failure, class II or greater cardiac conduction block, myocardial infarction in the past 6 months,, unstable arrhythmia or angina, cerebral infarction in the past three months, etc.) and lung diseases (interstitial pneumonia obstructive pulmonary disease and a history of symptomatic bronchospasm). 10. Has received a live vaccine within 30 days prior to the first dose of trial treatment. 11. Patients with prior allogeneic stem cell or solid organ transplantation. 12. Major surgical procedure within 4 weeks prior to treatment other than for diagnosis. 13. A history of substance abuse and cannot be cured or mental disorders. 14. Patients with clinical symptoms of ascites or pleural effusion, need therapeutic puncture and drainage. 15. A history of malignancies in the past 5 years, excluding non-melanoma skin cancer, in situ cervical cancer; Evidence of any metastatic lesion outside the primary tumor site identified in the radiological evaluation within 5 years prior to treatment. 16. Other severe acute or chronic diseases, psychiatric conditions or laboratory abnormalities that may increase the risk of participating in the study or interfere with the interpretation of safety or efficacy evaluations. 17. Patients who do not meet the physical requirements for radical cystectomy or refuse radical cystectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (PCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related adverse events occurring throughout the study;Perioperative complication rate ; Clinical complete response(cCR) rate ;Downstaging rate; Proportion of patients who undergo cystectomy;Disease-free survival (DFS) rate at 2 years;; | — |
Countries
China
Contacts
Public ContactLiu Jiyan
West China Hospital of Sichuan University
Outcome results
None listed