Bladder Cancer
Conditions
Interventions
experimental group:Carrelizumab combined with GC regimen
Sponsors
Baotou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Expected survival period >= 3 months; 3. Inoperable patients with locally advanced or advanced initial treatment, or advanced bladder cancer that has received first-line chemotherapy and the disease has progressed or metastasized, and does not exceed second-line treatment. 4. Eastern Cooperative Oncology Group (ECOG) physical status score must be 0-1; 5. 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); 6. Advanced bladder urothelial carcinoma confirmed by histopathology, mixed cancer requires the main histological type to be urothelial carcinoma subtype; 7. Patients with locally advanced or advanced bladder cancer diagnosed as inoperable, with or without pelvic lymphadenopathy; 8. Sufficient hematology and terminal organ function within 4 weeks before the first study treatment, defined as follows: sufficient bone marrow reserve and organ function 9. Women should agree to use contraceptive measures (such as intrauterine device [IUD], contraceptives or condoms) during the study period and 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 contraception during the study period and within 6 months after the end of the study period; 10. The subject is willing to sign an informed consent form and can 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, without any intervention after adulthood can be included; 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. The subject has untreated central nervous system metastasis, and has previously received systemic, radical brain or meningeal metastasis therapy (radiotherapy or surgery), if imaging confirmed that the stability has been maintained for at least 1 month, and the whole body has been stopped Patients with sex hormone therapy (dose>10mg/day prednisone or other curative hormones) for more than 2 weeks without clinical symptoms can be included; 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 within 1 year; 4) clinically significant supraventricular or 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 weight heparin; 8. Any bleeding event with a severity level of CTCAE 5.0 of 2 or above occurred within 4 weeks before the first 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; 11. Patients who have previously received chemotherapy (including platinum-based chemotherapy), surgery, after the completion of the treatment (last medication), 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 hair loss) have not recovered to = 38.5 degrees C, or baseline white blood cell count > 15*10^9/L; 13. Patients with known interstitial lung disease or history or evidence of non-infectious pneumonia treated with corticosteroids; or patients who may interfere with the detec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;AE;PFS;DCR; | — |
Countries
China
Contacts
Public ContactLiXin
Baotou Cancer Hospital
Outcome results
None listed