Recurrent extensive-stage small cell lung cancer
Conditions
Interventions
Test group:Slulizumab
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signed written informed consent before any trial-related procedures were performed; 2.Aged >= 18 and 3 months; 10.Adequate organ function, subjects must meet the following laboratory indicators: 1) In the absence of granulocyte colony stimulating factor in the past 14 days, the absolute neutrophil count (ANC) >= 1.5 × 10^ 9 /L; 2) In the absence of blood transfusion in the past 14 days, platelets >= 100 × 10^ 9 /L; 3) Hemoglobin > 9g/dL in the absence of blood transfusion or erythropoietin in the past 14 days; 4) Total bilirubin = 60 ml/min; 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) Myocardial enzyme spectrum within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities are not clinically significant, they are also allowed to be enrolled); 11.For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be performed within 3 days before the first dose of study drug (Day 1 of Cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing women are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 12.If there is a risk of pregnancy, all subjects (both male and female) must use contraceptive measures with an annual failure
Exclusion criteria
Exclusion criteria: 1.Malignant diseases other than SCLC diagnosed within 5 years before the first administration of the drug (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ); 2.Currently participating in interventional clinical research treatment, or having received other study drugs or used study devices within 4 weeks before the first dose; 3.Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to first administration. Replacement therapy (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment; 4.Receiving systemic glucocorticoid therapy (excluding topical glucocorticoids via nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (= 2; 3) Myocardial infarction within 6 months before enrollment; 4) Unsatisfactory blood pressure control (systolic blood pressure>140 mmHg, d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Duration of remission; | — |
Countries
China
Contacts
Public ContactFang Ma
Second Xiangya Hospital of CSU
Outcome results
None listed