Bladder cancer
Conditions
Interventions
treatment group:Tisle + GC chemotherapy
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Able to provide a written informed consent form,understand and agree to comply with the requirements of the study and the evaluation schedule; 2. Both men and women, aged 18-75 years at the date of signing the ICF (or the legal age of informed consent specified by the jurisdiction in which the study is conducted); 3. Maximal TURBT 4. Patients(cT2-T4aN0-1M0) with TURBt histological confirmation and imaging evaluation of bladder urothelial carcinoma (also known as transitional cell carcinoma or urothelial cell carcinoma); Patients with mixed tumor histology were required to have urothelial carcinoma as the predominant histological type; 5. Patients who are suitable for cisplatin therapy must be identified for the investigators. Patients who are not candidates for cisplatin therapy must meet at least one of the following criterias: ECOG physical status 2 or Karnofsky physical status 60% to 70%; Creatinine clearance was lower than 1 mL/s; Hearing loss >= Grade 2 in the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE) 4th Edition; Peripheral neuropathy >= grade 2 in NCI-CTCAE 4th Edition; Level 3 heart failure in New York Heart Association; 6. No previous systemic chemotherapy for bladder cancer: a. For patients who had previously received neoadjuvant chemotherapy, radiotherapy or radical concurrent chemoradiotherapy for bladder cancer, there had been no treatment interval of at least 12 months from the last treatment to the date of enrollment; b. Local intravesical chemotherapy or immunotherapy should be completed at least 1 week before the initiation of neoadjuvant therapy; 7. Fresh or archived tumor tissue with relevant pathology reports must be available (approximately 15 tissue blocks of FFPE, at least 6 newly cut slices of unstained FFPE tissue). If no tumor tissue is on file, a fresh tumor biopsy sample must be taken at baseline. Acceptable samples include needle core biopsy samples (at least 3 cores) from deep tumor tissue or mucosal lesion samples from excision, incision, punch, or clamp biopsy. Fine needle aspiration, brushing, precipitated cells from urine, or lavage of samples are not acceptable; 8. There must be lesions (measurable or not) that can be evaluated according to RECIST v1.1. Note: A previously irradiated lesion should not be considered a target lesion unless the lesion shows disease progression since the last radiotherapy and no other lesion is available as a target lesion; 9. ECOG Physical status 0 or 1; 10. The patients had good organ function, as measured by the following laboratory test values during the screening period (obtained = 1.5 x 10^9/L; ii. Platelet >= 100 x 10^9/L; iii. Hemoglobin >= 90 g/L; b. International normalized ratio or activated partial thromboplastin time = 60 mL/min; d. Serum total bilirubin = 120 days after the last dose of tislelizumab, and have negative urine or serum pregnancy t
Exclusion criteria
Exclusion criteria: 1. Patients with hydronephrosis 2. Patients with extensive or multifocal carcinoma in situ 3. Previously received PD-1, PD-L1, PD-L2, CTLA4 targeted therapy or other antibodies or drugs specifically targeted at T-cell co-stimulation or checkpoint channels; 4. Have used any approved anticancer therapy, including hormonotherapy, or any other investigational agent, or participated in another clinical study for therapeutic purposes within 28 days prior to randomization; 5. Treatment with systemic immune stimulants (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 half-life periods of the drug before randomization; 6. Active leptomeningeal diseases; 7. Uncontrolled hypercalcemia, defined as one of the followings: a.Ionized calcium > 1.5 mmol/L; b.Serum calcium > 3 mmol/corrected serum calcium > ULN (if serum albumin 10 mg/day) or other immunosuppressive agents within the grade 1 after standard treatment, or >= grade 3 hypoalbuminemia; 13. A history of interstitial lung diseases, non-infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc.; 14. Severe chronic or active infections (including tuberculosis) requiring systemic antibacterial, antifungal,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Complete Response (cCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bladder Intact Disease-Free Survival rate; | — |
Countries
China
Contacts
Public ContactJunxing Chen
The First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed