Extensive-stage small cell lung cancer, ES-SCLC
Conditions
Interventions
Experimental group:Envolizumab + irinotecan liposomes (II) + platinum
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent before implementing any procedures related to the trial; 2. Age >=18 years old and 3 months; 11. For adequate organ function, the subject must meet the following laboratory criteria: (1) In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) was >=1.5x10^9/L; (2) Platelets >=100×10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin >9g/dL in the last 14 days without blood transfusion or use of erythropoietin; (4) Total bilirubin ULN but direct bilirubin =60 ml/min; (7) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; (8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) The myocardial enzyme profile was within the normal range (if the researcher comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included); 12. For female subjects of reproductive age, a urine or serum pregnancy test should be performed negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; 13. If there is a risk of conception, all subject
Exclusion criteria
Exclusion criteria: 1. Symptomatic brain metastases; 2. Autoimmune diseases; 3. Received T cell co-stimulation or immune checkpoint therapy; 4. Active infection; 5. Known allergy to the investigatory drug: known severe allergic reactions to monoclonal antibodies of any kind and a history of allergy to ilican liposomes or platinum; 6. Pregnant or lactating women; 7. According to the judgment of the researcher, there are other circumstances that are not suitable for inclusion in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Security; | — |
Countries
China
Contacts
Public ContactWang Haiyong
Cancer Hospital Affiliated of Shandong First Medical University
Outcome results
None listed