Bladder urothelial carcinoma
Conditions
Interventions
Single arm experimental group:Tilelizumab combined with cisplatin, gemcitabine
Sponsors
Liaoning Cancer Hospital and Institute
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 to 75 years; 2. ECOG PS: 0 to 2 points; 3. Subjects need to undergo TURBT surgery and imaging diagnosis. The investigator judges that they are muscle-invasive bladder urothelial carcinoma (urothelial carcinoma is the main pathological component> 50%), and plans to undergo cystectomy (including partial urothelial carcinoma). cystectomy and radical cystectomy); 4. Clinical stage T2-T4a N0 M0 (CT/MRI + PET/CT); 5. Blood or histopathological detection of PD-LI expression >1% (Dako28-8 or Dako22C3) or tumor mutation load TMB >10 or MSI-H/dMMR; 6. Residual tumor lesions after TURBT (investigator's judgment) 7. Have TURBT tissue examination specimens; 8. Expected survival period >= 3 months; 9. The function of major organs is normal (14 days before enrollment), that is, the following criteria are met: (1) The blood routine examination criteria must be met (no blood transfusion and no granulocyte colony-stimulating factor treatment within 14 days before enrollment): HB >= 90 g/L; ANC >= 1.5x10^9/L; PLT >= 100x10 ^9/L; (2) Non-functional organic disease, the following criteria must be met: T-BIL 20ml/min (Cockcroft-Gault formula); (3) International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT): <= 1.5 x ULN (this criterion is only applicable to patients who have not received anticoagulation therapy; patients receiving anticoagulation therapy should use anticoagulant within the scope of the therapeutic requirements); 10. Have not received systemic corticosteroid therapy within 4 weeks before treatment; 11. Males of reproductive potential or females of potential pregnancy must use a highly effective method of contraception (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicide) during the trial, and Continue contraception for 12 months after treatment ends; 12. 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. Have received anti-PD-1, anti-PD-L1, and anti-PD-L2 treatments in the past; 2. Those who are known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 3. Those who have received other anti-tumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of the study treatment, or have not recovered from the last toxicity (except for 2nd degree alopecia and 1st degree neurotoxicity); 4. Pregnant or lactating women; 5. The HIV test result is positive; 6. Patients with active hepatitis B or C: HBsAg or HBcAb-positive patients also detect HBV DNA copy number positive (quantitative detection limit is 500IU/ml, or reach the positive value of copy number detected by the research center); this type of patient HBV DNA must be tested during research screening; patients with positive HCV antibody test results can only be selected for this study if the HCV RNA PCR test result is negative. 7. Have a clear history of active tuberculosis; 8. There are active autoimmune diseases that require systemic treatment in the past 2 years (such as the use of disease-modifying drugs, corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or renal or pituitary insufficiency) are allowed Physiologic corticosteroid replacement therapy); 9. Other serious and uncontrollable concomitant diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, uncontrollable diabetes, and cardiovascular disease (New York Heart Association classification Defined grade III or IV heart failure, heart block above II degree, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, etc.) or lung Disease (history of interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm); 10. Those who have received live vaccination within 4 weeks before the start of treatment; 11. Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 12. Those who have a history of psychotropic drug abuse and cannot be quit or have a history of mental disorders; 13. A large amount of pleural fluid or ascites accompanied by clinical symptoms or requiring symptomatic treatment; 14. People who have had other malignant tumors in the past 5 years that have not healed, but do not include malignant tumors that have been obviously cured, or curable cancers, such as basal skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, and cervical cancer Cancer or breast carcinoma in situ; Remarks: Localized low-risk prostate cancer (defined as patients with stage <= T2b, Gleason score <= 7 and PSA <= 20 ng/mL (as measured) at the time of prostate cancer diagnosis has received radical treatment Patients who are treated and have no biochemical recurrence of prostate specific antigen (PSA) can participate in this study); 15. Combined with urothelial carcinoma of the upper urinary tract (urinary pelvis, ureter, urothelial carcinoma) 16. According to the researcher's opinion, other severe, acute or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the research, or may interfere with the interpretation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| partialcystectomy; | — |
Countries
China
Contacts
Public ContactZeng Yu
Liaoning Cancer Hospital and Institute
Outcome results
None listed