Immune-related adverse reactions
Conditions
Interventions
IrAEs group:None
Non-IrAEs group:None
Sponsors
Changzhi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent and be willing to accept treatment and follow-up; 2. Men or women who are 18 years or older; 3. Have not received PD-1 monoclonal antibody treatment before; 4. EGCO score is 0-1; 5. Life expectancy is more than 3 months; 6. Provide paraffin tissue specimens accessible within 2 years; 7. The functions of vital organs meet the following requirements (any blood components, cell growth factor drugs are not allowed within 14 days before randomization): (1) Absolute neutrophil count >=1.5x10^9/L; (2) Platelets>=100x10^9/L; (3) Hemoglobin >=90 g/L; (4) Serum albumin>=30 g/L; (5) Thyroid-stimulating hormone (TSH)<=1xULN (if abnormal, the levels of FT3 and FT4 should be investigated at the same time, if the levels of FT3 and FT4 are normal, they can be included in the group); (6) Serum total bilirubin <=1xULN (within 7 days before randomization); (7) ALT and AST <=3xULN (within 7 days before randomization); (8) AKP <= 2.5xULN (with known bone metastases <= 5xULN); (9) Serum creatinine<=1.5xULN. 8. Non-surgical sterilization or female subjects of childbearing age who need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) during the study treatment and within 180 days after the end of the study treatment; non-surgical The sterilized female subjects of childbearing age must have a negative serum HCG test within 72 hours before randomization; and must be non-lactating; for male subjects whose partners are women of childbearing age, the study treatment period and the end of the study treatment period Use effective contraception for the next 180 days.
Exclusion criteria
Exclusion criteria: 1. Those who have received PD-1 monoclonal antibody treatment, and there are toxic and side effects of other previous anti-tumor treatment before this PD-1 monoclonal antibody treatment. 2. Received systemic systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, and interleukin) within 2 weeks before the first administration; 3. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. 4. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: the use of physiological doses of Glucocorticoids (= grade 2; 16. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, has occurred within 6 months before the selected treatment; 17. Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 18. There is a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there is currently clinically active interstitial lung disease; 19. Active pulmonary tuberculosis; 20. There is an active or uncontrolled infection that requires systemic treatment; 21. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; 22. Liver diseases such as liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis, liver cancer, liver metastases; 23. Poor co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood count;Liver function;Tumor markers;Coagulation function;Renal function;Blood glucose;Electrolyte;Fibrinolysis function;Examination items before blood transfusion;Immunoassay;Myocardial enzymes;Myocardial injury markers;brain natriuretic peptide;Head computed tomography scan;Thoracic and abdomen computed tomography scan + enhancement;Upper abdominal nuclear magnetic resonance;Color Doppler ultrasound of superficial lymph nodes;Echocardiography;lymphocyte cytoplasmic protein;ATP-dependent glucokinase;Patient-Supplied Subjective Global Nutritional Status Scale;Body Mass Index;Nutritional Risk Screening Form;Phase angle;Waist to hip ratio;Basal metabolic rate;Prealbumin;Hemoglobin;Urine test;Stool examination + Occult blood;Ferritin;Cytokines; | — |
Countries
China
Contacts
Public ContactZhang Xiaoling
Changzhi People's Hospital
Outcome results
None listed