Tumors of the biliary system
Conditions
Interventions
Sponsors
the First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. Advanced biliary system tumors diagnosed by histopathology or cytology; 3. ECOG score 0 or 1 point; 4. At least one measurable lesion (mRECIST standard); 5. The main organs and bone marrow function are basically normal: (1) Blood routine: white blood cells >=4.0 x 10^9/L, neutrophils >=1.5 x 10^9/L, platelets >=100 x 10^9/L, hemoglobin >=90g/L; (2) International normalized ratio (INR) 60mL/min; (5) The heart function is normal, and the left ventricular ejection fraction (LVEF) measured by two-dimensional echocardiography >=50%; 6. Fully understand this study, volunteer to participate, receive camrelizumab treatment, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; 2. Women who are pregnant or breastfeeding; 3. Those deemed unsuitable for inclusion by the doctor; 4. Incomplete important imaging examinations and incomplete records of adverse reactions; 5. 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 those without any intervention after adulthood can be included; patients with asthma that require bronchodilators for medical intervention cannot be included); 6. Patients with any severe and/uncontrolled diseases, including: patients with unsatisfactory blood pressure control (systolic blood pressure >=150 mmHg or diastolic blood pressure >=100 mmHg); patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (Including QT interval 480ms) and grade I cardiac insufficiency; active or uncontrolled severe infection; liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA 104 copies/ml or 2000IU/ ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method); urine routine indicates that urine protein >=++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0g; 7. Known to have inherited or acquired bleeding and thrombotic tendency, such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.; 8. Received major surgery, open biopsy, or major trauma within 28 days before starting the medication, or received abdominal intervention or major abdominal trauma within 60 days before starting the study treatment, or expected major surgery during the study period The operation or failure to recover from the side effects of any such operation; 9. Severe infections within 4 weeks before starting the study treatment, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia; 10. 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 enrollment; 11. Patients with brain metastases who have symptoms or who have been under symptom control for less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival ;Objective response rate ;Disease control rate; | — |
Countries
China
Contacts
Public ContactLi Jie
the First Affiliated Hospital of Zhengzhou University
Outcome results
None listed