Lung Cancer
Conditions
Interventions
treatment group:Surgery
Serlulimab 4.5mg/Kg intravenous drip Q3W, 2 cycles-4 cycles
Etoposide 100mg/m2 D1-D3 plus Carboplatin (AUC=5) D1 Q3W, 2 cycles-4 cycles
Sponsors
Department of Respiratory, the Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)The subjects voluntarily joined the study and signed the informed consent; 2)The subjects are 18=age=75 years old at the time of signing the informed consent, male or female; 3)Patients with histopathologically confirmed small cell lung cancer (according to WHO classification 2015) ; 4)Stage IIB-IIIB small cell lung cancer patients; 5)The subjects had not previously received any treatment for small cell lung cancer; 6)According to RECIST 1.1, there was at least one single-diameter measurable lesion whose longest diameter was measured by spiral CT =10mm; 7)ECOG PS is 0 or 1; 8) Both men and women of childbearing age agreed to use a reliable method of contraception before entering the study, during the study and up to eight weeks after drug discontinuance; 9)Patients who have consented to surgery; 10)The specialist identifies patients with no contraindications to surgery. The major organs are functional and should meet the following criteria: (1)Pulmonary ventilation function test, FEV1=1.5L, or expected FEV1=800 ml after lobectomy/pneumonectomy; (2) Blood routine test standard (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors) : a. Hemoglobin (HB) =90g/L; b. Neutrophil absolute value =1.5x10^9/L; c. Platelet=80x10^9/L; The biochemical examination must meet the following criteria: a. Total bilirubin =1.5 times the upper limit of normal value; b. Alanine transferase (ALT) and aspartate aminotransferase (AST) =2.5xULN; c. Serum creatinine =1.5xULN or creatinine clearance =60ml/min. Women of childbearing age (15-49 years old) must undergo a urine pregnancy test within 7 days before starting treatment and the result must be negative.
Exclusion criteria
Exclusion criteria: 1)Combined with other tumors; 2)The primary lesion was evaluated as T4; 3)The tumor is inoperable near or surrounding large blood vessels; 4)Any systemic or local anti-cancer treatment for small cell lung cancer; 5)Lymph node metastasis was N3; 6)Systemic immune stimulants (including but not limited to interferon, interleukin 2, and tumor necrosis factor) were administered within 4 weeks prior to enrollment or within 5 half-lives of the drugs; 7)Any Chinese herbs used to control cancer were used within 14 days before the study drug was first administered; 8)Patients with any disease for which systemic treatment with corticosteroids (prednisone>10mg/ day or equivalent treatment) or other immunosuppressive agents was required during the first 14 days of enrollment, patients who were currently or previously on any of the following steroid regimens were eligible for inclusion: adrenergic replacement steroids (prednisone =10mg/ day or equivalent treatment); Inhaled corticosteroids with very low local, ocular, intra-articular, nasal; A short course (=7 days) of prophylactic use of prescription corticosteroids (e.g., for contrast media allergy) or for the treatment of non-autoimmune diseases (e.g., delayed allergic reactions caused by contact allergens); 9)Patients with cancers other than small cell lung cancer in the five years prior to the start of treatment in this study; 10) Allergic to any of the ingredients in Serplulimab or chemotherapy drugs; 11)Patients with any severe/uncontrolled disease, including: a. Patients with unsatisfactory blood pressure control (systolic blood pressure=15mmHg, diastolic blood pressure=100mmHg) ; b. Patients with grade I or higher myocardial ischemia or obstruction, arrhythmias (including QTc=480ms), and grade 2 congestive heart failure; c. Active or uncontrolled severe infection; 12) Pregnant or lactating women; 13) Patients have uncontrollable neurological, mental illness or mental disorder, poor compliance, inability to cooperate and describe treatment; 14) Patients refused surgery; 15) The investigators determined that the patient may have other factors that may have forced the study to be terminated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response;Major Pathologic Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate;2-year overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactXu Zhi
Department of Respiratory, the Second Affiliated Hospital of Army Medical University
Outcome results
None listed