small-cell lung cancer
Conditions
Interventions
Experimental group:Neoadjuvant therapy:
Cohort 1:Adebrelimab:1200mg, D1,Q3W
Cisplatin 75mg/m2, D1,or Carboplatin AUC=5,D1,Q3W
Etoposide 100mg/m2,D1-3,Q3W,2cycles.
Cohort 2:Adebrelimab:1200mg, D1,Q3W
Etoposide 100mg/m2,D1-3,Q3W,3cycles.
Surgery:
After 4–6 weeks of neoadjuvant therapy, patients deemed operable by a surgeon will undergo surgery, while those deemed inoperable will receive concurrent
Sponsors
Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years old, both men and women; 2.Histopathology or cytologically confirmed small-cell lung cancer ; 3.Clinical stage classified as locally advanced: T1-4N0-2M0; 4.Have not received any systemic anti-tumor treatment or chest radiotherapy; 5.No surgical contraindications after surgeon evaluation; 6.At least one measurable lesion(According to RECIST 1.1); 7.ECOG: 0~1; 8.Expected survival period >= 3 months; 9.Major organ function has to meet the following certeria: (1) Blood routine examination: a)HB >= 90g/L; b)ANC >=1.5 × 10^9 / L; c)PLT >= 100 × 10^9 / L; (2) Biochemical examination: a)ALB >=30g/L; b)ALT and AST<2.5ULN; c)TBIL <= 1.5ULN; d) Cr <= 1.5ULN; (3) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) <=1.5 × ULN. 10.Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily agree to use appropriate contraceptive methods during the study period and for 8 weeks after the last dose of the study drug. For males, they should agree to use appropriate contraceptive methods during the study period and for 8 weeks after the last dose of the study drug. 11.Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1.Other pathological types: mixed small cell lung cancer; 2.Patients with a known history of allergy, or known or suspected allergy or intolerance to the study drug or any drug related to this trial; 3.Use of immunosuppressive agents (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) continuously for 7 days prior to the first dose, except for prednisolone at a dose not exceeding 10 mg/day or equivalent physiological doses of other corticosteroids. Intranasal and inhaled corticosteroids or physiological doses of systemic corticosteroids are not excluded; 4.Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), history of clinically active pneumonia, or other moderate-to-severe pulmonary diseases that significantly affect lung function; 5.Active tuberculosis (TB) or history of active TB infection within 48 weeks prior to enrollment, regardless of treatment history; 6.Vaccination with or planned vaccination against preventive vaccines or live attenuated vaccines within 4 weeks prior to the first dose; 7.Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, enteritis, systemic lupus erythematosus, rheumatoid arthritis). Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included. Asthma requiring bronchodilators for medical intervention is not eligible; 8.HBsAg positive with a value exceeding the upper limit of normal (1000 copies/mL or 500 IU/mL). Patients with a history of hepatitis B virus (HBV) infection or resolved HBV infection may be included if HBV DNA is within normal limits at screening. HCV antibody positive with HCV viral titer exceeding the upper limit of normal, or HCV RNA or HCV Ab indicating acute or chronic infection. Known history of HIV positivity or known acquired immunodeficiency syndrome (AIDS); 9.Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors: a)Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) class 3 or 4 heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular or cerebrovascular diseases within 6 months prior to enrollment; b) Any deep vein thrombosis (patients may be enrolled if stable for =2 weeks on low molecular weight heparin or similar therapeutic agents), peripheral arterial thromboembolic event, pulmonary embolism, or other serious thromboembolic events within 3 months prior to enrollment; c) Presence of major vascular diseases that may be life-threatening or require surgery within 6 months, such as aortic aneurysm or aortic dissecting aneurysm; d) Left ventricular ejection fraction (LVEF) <50% on echocardiography, or currently uncontrolled hypertension defined as systolic blood pressure =130 mmHg and/or diastolic blood pressure =80 mmHg; 10.Major surgery or severe traumatic injury, fracture, or ulcer within 4 weeks prior to enrollment, or planned major surgery during the study period; 11.Severe sepsis or septic shock, including but not limited to hospitalization due to complications such as infection, bacteremia, or severe pneumonia, within 14 days prior to enrollment; 12.Other malignancies requiring treatment within 5 years (excluding basal cell
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response ( pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response(MPR);R0 Resection Rate;Objective Response Rate (ORR);Event-Free Survival(EFS);Overall Surviva (OS);Adverse Events ; | — |
Countries
China
Contacts
Public ContactYang liwei /Wang Ping
Fourth Hospital of Hebei Medical University
Outcome results
None listed