Advanced solid tumors with sepsis
Conditions
Interventions
SHR-1210 group:SHR-1210 200 mg intravenous injection once
control group:Placebo intravenous injection
Sponsors
The Affiliated Tumor Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. advanced solid tumors; 2. Sepsis diagnosis according to the sepsis standard3.0 (SOFA score > 2); 3. aged = 18 years old; both Men and women; 4. volunteers join in this study with good compliance and matched follow-up, sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. patients had any active or medical history of autoimmune disease; 2. Patients were treated with immunosuppressive agents or systemic or local absorbable hormones(Dose > 10mg/prednisone or other therapeutic hormones) in 14 days before the study drug is given; 3. severe hypersensitivity reaction to other monoclonal antibodies; 4. Women in pregnancy or lactation; 5. Human immunodeficiency virus (HIV) infection; 6. Coagulation function impaired, hemorrhagic tendency or undergoing thrombolytic or anticoagulant therapy; 7. Exist hereditary or acquired hemorrhage and thrombosis tendency(such as Hemophilia, coagulation dysfunction, thrombocytopenia); 8. patients were treated with other PD-1 antibodies or other immunotherapy against PD-1/PD-L1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28 day mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| ICU stay time;duration of mechanical ventilation;7 day mortality; | — |
Countries
China
Contacts
Public ContactKaijiang Yu
The Affiliated Tumor Hospital of Harbin Medical University
Outcome results
None listed