pan-tumour
Conditions
Interventions
Adverse reaction group:None
Control group:N/A
Sponsors
XiangYang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with solid malignant tumors diagnosed by pathological tissue 2.Treatment with PD-1 or PD-L1 in combination or monotherapy 3.Age 18-75 years ; 4.ECOG score 0-2 points ; 5.Major organ function levels meet the following criteria : 1 ) 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 ) Biochemical tests should meet the following criteria : TBIL = 2.0 × ULN, ALT, AST = 2.5 × ULN. BUN and CRE = 1.5 × ULN or endogenous creatinine clearance = 60ml / min. ( Cockcroft-Gault formula ) ; 3 ) Good coagulation function : defined as international normalized ratio ( INR ) or prothrombin time. ( PT ) = 1.5 ULN ; if the subject is receiving anticoagulant therapy, as long as PT is in anticoagulation Drugs can be used within the scope of the proposed ; 4 ) myocardial enzymes in the normal range ; 6.Subjects voluntarily joined the study, signed informed consent, good compliance, with follow-up
Exclusion criteria
Exclusion criteria: 1. Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, Uveitis, enteritis, hepatitis, hypophysitis, Vasculitis, Myocarditis, nephritis, hyperthyroidism, hypothyroidism [can be included after hormone replacement therapy is normal]); Patients with Vitiligo or asthma in childhood that has completely alleviated and does not need any intervention after adulthood can be included, and patients with asthma who need medical intervention with Bronchiectasis cannot be included; Patients who use hormones (excluding local use) due to the above or other reasons; 2.Patients with congenital or acquired immune dysfunction ( such as HIV infection ), active hepatitis B ( HBV-DNA = 10^3 copies / ml ) or hepatitis C ( hepatitis C antibody positive, and HCR-RNA is higher than the lower limit of detection of the analytical method ) ; 3.Patients with uncontrolled cardiovascular disease : myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia ( including QTc interval = 470 ms ) ; according to NYHA standard, grade III ~ IV cardiac insufficiency, or left ventricular ejection fraction ( LVEF ) < 50 % by echocardiography ; myocardial infarction occurred within 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T cell populations; | — |
Secondary
| Measure | Time frame |
|---|---|
| cytokine; | — |
Countries
China
Contacts
Public ContactWEI WEI
XiangYang Central Hospital
Outcome results
None listed