Bladder urothelial carcinoma
Conditions
Interventions
Experimental group:Tilelizumab combined with cisplatin and gemcitabine
Sponsors
Shengjing Hospital Affiliated to China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged >= 18 and = 3 months; 6. The investigator must determine patients who are suitable for cisplatin or carboplatin treatment; 7. For patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or concurrent chemoradiation for UC, there has been a treatment interval of at least 12 months from the last treatment to the date of relapse. Local intravesical chemotherapy or immunotherapy should be completed at least 4 weeks before the start of the study treatment; 8. The function of major organs is normal (14 days before enrollment), which means that the following criteria are met: (1) Routine blood examination standards must meet (no blood transfusion and no treatment with granulocyte colony stimulating factor within 14 days before enrollment): HB >= 90 g/L; ANC >= 1.5 x 10^9/L; PLT >= 100 x 10^9/L; (2) Non-functional organic diseases shall meet the following standards: T-BIL = 45 ml/min, if cisplatin is used, calculated creatinine clearance rate >= 60 ml/min (Cockcroft-Gault formula); (3) International normalized ratio (INR), activated partial thromboplastin time (aPTT): <=1.5 x ULN (this standard only applies to patients who have not received anticoagulant therapy; patients who receive anticoagulant therapy should make anticoagulant Within the scope of treatment requirements); 9. Have not received systemic corticosteroid treatment within 4 weeks before treatment; 10. Reproductive men or women who are likely to become pregnant must use highly effective contraceptive methods (such as oral contraceptives, intrauterine contraceptives, sexual control or barrier contraception combined with spermicide) during the trial, and Continue contraception for 12 months after the end of treatment; 11. Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Have received anti-PD-1, anti-PD-L1, and CTLA4 targeted therapy for UC 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 treatments (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. Active hepatitis B or C patients: HBsAg or HBcAb-positive patients also have positive HBV DNA copy number (quantitative detection limit is 500 IU/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 carcinoma in situ or breast carcinoma in situ; Remarks: localized low-risk prostate cancer (pwith stage <= T2b, Gleason score <= 7, and PSA <= 20 ng/mL (as measured) at the time of prostate cancer diagnosis who have received curative treatment and have no prostate-specific antigen [PSA] biochemical recurrence were eligible to participate in this study); 15. Combined with urothelial carcinoma of the upper urinary tract (urinary pelvis, ureter, urothelial carcinoma);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Tolerability;Duration of efficacy (DOR);Overall survival; | — |
Countries
China
Contacts
Public ContactYin Bo
Shengjing Hospital Affiliated to China Medical University
Outcome results
None listed