adverse reactions related to immunotherapy in malignant tumors
Conditions
Interventions
Adverse reaction group:immunotherapy
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Solid malignant tumor patients diagnosed by pathological tissue; 2. Accept PD-1 or PD-L1 combination or monotherapy treatment; 3. Age range from 18 to 75 years old; 4. ECOG score 0-2 points; 5. The functional level of the main organs should meet the following standards: 1) The blood routine examination standards should meet: WBC >= 3.0 × 10 ^ 9/L, ANC >= 1.5 × 10 ^ 9/L, PLT >= 100 × 10 ^ 9/L, Hb >= 90g/L. 2) The biochemical examination should meet the following standards: TBIL = 60ml/min (Cockcroft Gault formula); 3) Good coagulation function: defined as international standardized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; If the subject is receiving anticoagulant treatment, as long as the PT is within the intended range of use of the anticoagulant drug; 4) The myocardial enzyme spectrum is within the normal range; 6. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
Exclusion criteria
Exclusion criteria: 1. Suffering from any active autoimmune disease or having a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, thyroiditis) Reduced glandular function [can be included after normal hormone replacement therapy]; Suffering from vitiligo or having childhood asthma Completely relieved and can be included in adults without any intervention, requiring medical intervention with bronchodilators Asthma patients cannot be included; Patients who use hormones (excluding local use) for the above or other reasons; 2. People with congenital or acquired immune deficiency (such as HIV infected people), active hepatitis B (HBV-DNA >= 103 copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCR-RNA is higher than the detection limit of the analytical method); 3. Suffering from uncontrolled cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >= 470 ms); According to NYHA standards, patients with grade III-IV cardiac dysfunction or those with left ventricular ejection fraction (LVEF)<50% indicated by echocardiography; Have experienced myocardial infarction within 1 year;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Genomic changes before and after receiving immunotherapy;Changes in plasma cytokines before and after receiving immunotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Basic clinical information;Laboratory test results; | — |
Countries
China
Contacts
Public ContactDong ZHongyi
Southern Medical University Southern Hospital
Outcome results
None listed