upper urinary tract urothelial carcinoma
Conditions
Interventions
experimental group:tislelizumab + vedicetumab
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Upper urothelial carcinoma of the upper urinary tract confirmed by histopathology or cytopathology, with clinical stage cT2-4N0-2M0 or cTanyN1-2M0. Specifically, it may include any of the following high-risk factors: Multifocal tumor on imaging or ureteroscopy; high-grade tumor on urine exfoliative cytology; histological biopsy (including but not limited to ureteroscopy, percutaneous needle biopsy or surgical biopsy) suggestive of high-grade tumor; imaging findings suggestive of muscle invasion or local progression (as determined by the investigator); presence of ipsilateral hydronephrosis; prior bladder surgery specimens suggestive of high-grade tumor; variant histology histology); 2. The urologists participating in the clinical trial evaluate the ability to perform radical nephroureterectomy after neoadjuvant therapy; 3. Baseline examination: neutrophils > 1500 cells/mm3, platelets >= 100,000 cells/mm3, bilirubin = 30 ml/min; 4. Agree to provide tissue test specimens; 5. The main organ function is normal (14 days before enrollment), that is, it meets the laboratory test standards related to chemotherapy and immunotherapy; 6. No systemic corticosteroid treatment within 4 weeks before treatment; 7. Males of reproductive potential or females of potential pregnancy must use a highly effective contraceptive method (e.g., oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicide) during the trial, and Continue contraception for 12 months after treatment ends. If the subject is a female of childbearing age, a serum blood test should be performed to confirm that she is not pregnant; 8. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with non-organ-confined bladder cancer; 2. Systemic anti-tumor therapy (including chemotherapy, immunotherapy, etc.) for UTUC and radiotherapy targeting the area where the tumor is located. Patients who have undergone diagnostic resection of bladder tumor and/or local cystectomy and patients who have only undergone intravesical infusion chemotherapy are allowed to enroll; 3. Known or suspected hypersensitivity to tislelizumab, gemcitabine and cisplatin; 4. Existing or coexisting bleeding disorders; 5. Other uncontrollable inoperable patients; 6. HIV test result is positive; 7. Patients with active hepatitis B or C; positive for HBsAg or HBcAb, and HBV DNA copy number >= 1,000 IU/ml; positive for HCV antibody, only when the PCR test result of HCV RNA is negative can be included in this study; 8. Have a clear history of active tuberculosis; 9. Active autoimmune disease requiring systemic treatment within the past 2 years (such as use of corticosteroids or immunosuppressive drugs), allowing related replacement therapy (such as thyroxine, insulin, or renal or pituitary insufficiency of physiological cortex) steroid replacement therapy); 10. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with the interpretation of results, including active infection, uncontrolled diabetes, cardiovascular disease (class III or IV heart failure defined by the New York Heart Association classification), second-degree or higher heart block, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, etc.) or lung disease (interstitial pneumonia, obstructive history of lung disease and symptomatic bronchospasm); 11. Those who have received live vaccine within 4 weeks before the start of treatment; 12. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past; 13) Major surgical operations (excluding diagnostic surgical operations) within 4 weeks before the start of treatment; 14. Those who have a history of psychotropic substance abuse and cannot quit or those who have a history of mental disorders; 15. Massive pleural effusion or ascites accompanied by clinical symptoms or requiring symptomatic treatment; 16. Patients with a history of other malignant tumors in the past 5 years, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; other early malignant tumors that have not been systematically treated have no recurrence and metastasis for more than 5 years after local radical treatment, Those who were assessed by the investigator and determined that the bladder lesions were non-metastatic lesions were eligible for inclusion; 17. Accompanied by other serious diseases, such as severe active infection, etc.; 18. Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that may increase the risks associated with participating in the study, or may interfere with the interpretation of the study results, in the opinion of the investigator; 19. Patients who are not eligible for radical surgery or who refuse radical surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR, pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, Overall Survival;The remission rate of most tumors;Progression-free survival;LRFS, local recurrence-free survival;DMFS, distant metastasis-free survival;ORR, Objective Remission Rate; | — |
Countries
China
Contacts
Public ContactWei Qiang
West China Hospital, Sichuan University
Outcome results
None listed