urothelium carcinoma
Conditions
Interventions
test group :carrelizumab combined with GC
Sponsors
Baotou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years old; 2.Expected survival period >= 3 months; 3.The Eastern Cooperative Oncology Group (ECOG) physical status score must be 0-1 points; 4.There is at least one measurable lesion that meets the RECISTv1.1 standard (according to the requirements of RECISTv1.1, the long diameter of the spiral CT scan of the measurable lesion is >=10mm or the short diameter of enlarged lymph nodes is >=15mm); 5.Locally advanced bladder urothelial carcinoma confirmed by histopathology, no evidence of metastatic lesions, mixed type cancer requires that the main histological type is urothelial carcinoma subtype; 6.Have not undergone chemotherapy with platinum-based regimens in the past; 7.Clinically diagnosed as locally advanced bladder cancer patients, with or without pelvic lymphadenopathy (cT2-T4a, N0-1, M0); 8.Appropriate and plan for radical cystectomy (according to the guidelines); 9.Sufficient hematology and end-organ function within 4 weeks before the first study treatment, defined as follows: Have sufficient bone marrow reserve and organ function: (1)Neutrophil count (ANC) >=1500/mm^3 (in the first cycle, there is no granulocyte colony stimulating factor support within 2 weeks before the first day); (2)White blood cell count (WBC)>2500/µL; (3)Lymphocyte count >=500/µL; (4)Platelet count (PLT) >=100,000/mm^3 (in cycle 1, no blood transfusion within 2 weeks before day 1); (5)Hemoglobin (Hb) >=9 g/dL (patients can receive blood transfusion or receive erythropoiesis therapy to meet this standard); (6)Serum creatinine (Cr) = 60 mL/min (Cockcroft-Gault formula); (7)Total bilirubin (BIL) <= 1.5 times the upper limit of normal (ULN); (8)Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) level <=2.5 times the upper limit of normal (ULN) (Patients with Gilberts disease are known to have serum bilirubin levels <=3xULN of institutions can participate ); (9)International normalized ratio (INR) <= 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) <=1.5 times ULN (this is only applicable to patients who have not received therapeutic anticoagulation therapy; Receiving therapeutic Patients on anticoagulant therapy should take a stable dose); 10.Women should agree to use contraceptive measures (such as intrauterine device [IUD], contraceptives or condoms) during the study period and within 6 months after the end of the study; Serum or urine pregnancy test within 7 days before study entry Negative, and must be a non-lactating patient; Men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 11.The subjects are willing, understand and sign the informed consent form, and are able to abide by the agreement.
Exclusion criteria
Exclusion criteria: 1.The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , Hyperthyroidism; patients suffering from vitiligo; asthma has been completely relieved in childhood, and can be included in adults without any intervention; patients with asthma that require bronchodilators for medical intervention cannot be included); 2.The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before the first administration; 3.Severe allergic reaction to other monoclonal antibodies; 4.Subjects had untreated transfer of central nervous system, always received systemic, radical brain or meningeal metastasis treatment (radiation therapy or surgery), such as imaging stability has been maintained at least a month, and have stopped systemic sex hormone therapy (> 10 mg/day dose effect of hormones such as prednisone or other) greater than 2 weeks, no clinical syndrome of patients can be incorporated into; 5.Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmHg); 6.There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular or clinically significant Ventricular arrhythmia requires treatment or intervention; (5) QTc>450ms (male); QTc>470ms (female); (6) Exclude cardiac ejection fraction EF>50%. 7.Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow the preventive use of low-dose aspirin and low molecular heparin; 8.Any bleeding event with severity grade 2 or higher in CTCAE 5.0 within 4 weeks prior to initial administration; 9.Imaging shows that the tumor has invaded important blood vessels or the researcher has judged that the patient's tumor is highly likely to invade important blood vessels and cause fatal bleeding during treatment; 10.Arterial/venous thrombosis events that occurred within 6 months before the first administration, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 11.Patients who have previously received chemotherapy (including platinum-based chemotherapy), surgery, after the completion of the treatment (last medication), and less than 4 weeks before the study medication; less than 2 weeks after palliative radiotherapy; molecular targeted therapy (including other clinical trials) Oral targeted drugs) are less than 5 drug half-lives from the first study drug, or the adverse events caused by previous treatment (except for alopecia) have not recovered to =38.5?, or baseline white blood cell count >15x10^9/L; 14.Patients who are known to have interstitial lung disease or have a history or evidence of non-infectious pneumonia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;disease control rate;safety;disease free survival;overall survival;12-month survival rate;tolerance; | — |
Countries
China
Contacts
Public ContactLi Xin
Baotou Cancer Hospital
Outcome results
None listed