Solid tumor
Conditions
Interventions
Case series:No
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, no gender limit; 2. Patients with solid tumors confirmed by histopathology or cytology; 3. At least one measurable lesion (according to RECIST 1.1 standard); 4. Patients with solid tumors who have failed previous radiotherapy and chemotherapy; 5. The main organs and bone marrow function are basically normal: (1) Blood routine: white blood cells >=4.0x10^9/L, neutrophils >=1.5x10^9/L, platelets >=100x10^9/L, hemoglobin >=90g/L; (2) Liver function: total bilirubin60mL/min; (4) International normalized ratio (INR)=50%. 6. The ECOG score is 0 or 1; 7. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy tests are negative within 7 days before the study is enrolled , 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; 8. Observed patients joined the study voluntarily, signed an informed consent form, had good compliance, and cooperated with the follow-up.
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 those 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 enrollment; 3. Those who are known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; 4. Patients with brain metastases who have symptoms or whose symptom control time is less than 3 months; 5. Patients with any severe and/uncontrolled diseases, including: patients with unsatisfactory blood pressure control (systolic blood pressure >=150mmHg 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; 6. Pulmonary hemorrhage with NCI CTC AE grade> Grade 1 occurred within 4 weeks before enrollment; bleeding in other parts with NCI CTC AE grade> Grade 2 occurred within 4 weeks before enrollment; hemorrhage tendency (such as active peptic ulcer) Or patients who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or their analogues; 7. The investigator judges other conditions that may affect the conduct of clinical research and the determination of research results; 8. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ;Disease control rate ;Median progression-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of mitigation;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactJiao Dechao
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed