small cell lung cancer
Conditions
Interventions
Test group:Neoadjuvant therapy
On the first day of each cycle, intravenous drip of adebrelimab was administered, followed by etoposide 100mg/m2 d1, 2, 3, and carboplatin AUC 5 mg/mL · min d1, a total
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria in order to be eligible to enter this study. (1) The subjects voluntarily joined this study, signed an informed consent form, and cooperated with follow-up; (2) IIB-IIIA stage small cell lung cancer confirmed by histology/cytology (according to AJCC 8th edition); (3) Expected to achieve R0 resection for patients; (4) =28 days before the first study drug, CT or MRI scan with at least one measurable tumor lesion (meeting RECIST 1.1 standard) (5) Has not received anti-tumor treatment in the past; (6) Age range from 18 to 75 years old, regardless of gender; (7) Plan to undergo surgical treatment after the completion of neoadjuvant therapy; (8) There are no contraindications for surgery in preoperative functional examinations of various organs; (9) ECOG PS: 0-1 points; (10) The function of important organs meets the following requirements (no blood components or cell growth factors are allowed to be used 2 weeks before the start of research and treatment): 1) The blood routine examination must comply with: a) Absolute neutrophil count (ANC) = 1.5 × 109/L; b) Hemoglobin (HB) = 9g/dL; c) Platelet (PLT) = 100 × 109/L; d) Serum albumin (ALB) = 2.8g/dL. 2) Biochemical examination must comply with: a) Total bilirubin (TBIL) = 1.5 × ULN; b) ALT, AST = 2.5 × UILN (= 5 if abnormal liver function is caused by liver metastasis) × ULN); c) Serum creatinine sCr = 1.5 × ULN, endogenous creatinine clearance rate = 50ml/min (Cockcroft Fault formula); d) Thyroid function is normal. (11) Expected survival time = 3 months; (12) Researchers have determined that patients can receive adebrelimab combined with synchronous chemotherapy; (13) Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours before receiving the first study drug administration, and demonstrate a negative result. They are willing to use effective methods of contraception from the trial period to 3 months after the last administration of adebrelimab; For male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last administration of adebrelimab.
Exclusion criteria
Exclusion criteria: If a subject meets any of the following conditions, they will not be allowed to enter this study: (1) Known allergies to the study drug or any of its excipients; Or have experienced severe allergic reactions to other monoclonal antibodies; (2) Merge with other tumors; (3) Suffering from any active autoimmune disease or having a history of autoimmune diseases, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement therapy can be included after normal treatment); (4) Suffering from cachexia; (5) Hypertension that cannot be well controlled after treatment with antihypertensive drugs (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg); (6) HBsAg positive and HBV DNA detection value exceeds the upper limit of normal value (1000 copies/mL or 500IU/mL), or HCV positive (HCV RNA or HCV Ab testing indicates acute or chronic infection), or known HIV positive medical history or known AIDS; (7) Subjects who are undergoing systemic treatment with corticosteroids (>10mg/day, prednisone therapeutic dose) or other immunosuppressants within 14 days prior to the first use of the study drug; In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids and adrenal cortical hormone replacement with a dose greater than 10mg/day and a therapeutic dose of prednisone; (8) Subjects who have experienced severe infections within 4 weeks prior to the first medication use, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc; Excluding subjects with any active infections; The lymphatic spread of lung cancer cannot be ruled out; (9) Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval = 450 ms for males and = 470 ms for females). According to the NYHA standard for grade III-IV cardiac dysfunction or color Doppler ultrasound examination: subjects with LVEF (left ventricular ejection fraction)<50%; (10) Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders; (11) According to the judgment of the researchers, the subjects may have other factors that may cause them to be forced to terminate the study midway, such as suffering from other serious diseases (including mental illness) requiring concurrent treatment, severe abnormal laboratory test values, family or social factors, and difficulty in long-term follow-up; (12) The researcher determined that other situations were not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response;objective response rate;Event free survival time;overall survival;R0 resection rate;Adverse events (AE) and severe adverse events (SAE) evaluated according to CTCAE 5.0; | — |
Countries
China
Contacts
Public ContactHaiyong Wang
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed