SCLC
Conditions
Interventions
Experimental Group:Adebrelimab + Chemotherapy
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and 1 cm on CT scan; if necessary, confirmation by PET/CT or lymph node biopsy is required, and the patient must be considered potentially amenable to curative-intent surgical resection; 3. PD-L1 expression should be tested in all patients, but no restriction on PD-L1 expression level is applied; 4. Presence of measurable lesions per RECIST 1.1; 5. ECOG performance status 0–1; 6. Assessed by the clinician as able to tolerate preoperative neoadjuvant chemotherapy or immunochemotherapy; 7. Laboratory and instrumental findings meeting the following requirements: Hematology Absolute neutrophil count (ANC) >=1.5×10?/L (without use of hematopoietic growth factors within 14 days before the first dose of study therapy); White blood cell count (WBC) >=3.0×10?/L and =0.5×10?/L; Platelet count (PLT) >=100×10?/L (without blood transfusion within 14 days before the first dose); Hemoglobin (Hb) >=90 g/L; Blood biochemistry Total bilirubin (TBIL) =50 mL/min (Cockcroft-Gault formula); INR and APTT =50%; 12-lead ECG: corrected QT interval (QTc) <470 ms in females; 8. No contraindications to immune checkpoint inhibitors as confirmed by hematological evaluation; 9. No contraindications to surgery as confirmed by echocardiography, pulmonary function tests, and arterial blood gas analysis; 10. Voluntary participation with written informed consent, expected good compliance, and willingness to cooperate with the study protocol; 11. Female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must voluntarily agree to use appropriate contraceptive methods during the study period and for 4 months after the last dose of the study drug;
Exclusion criteria
Exclusion criteria: 1.Tumor-related symptoms and treatment 1) Clinical stage IA, IIIB, or IV SCLC; 2) Histologically or cytologically confirmed non-SCLC; 3) Multiple primary lesions; 4) Presence of surgical contraindications; 5) Receipt of any anti-tumor therapy (including surgery, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biotherapy, or tumor embolization) within 12 months prior to signing informed consent; 6)Deemed unsuitable for surgery by multidisciplinary team (MDT) evaluation. 2.Comorbidities/medical history 1) Other active malignancies within 5 years prior to signing informed consent, or concurrent other active malignancies. Exceptions: cured localized tumors such as basal cell carcinoma of the skin, squamous cell 2) carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, etc. 3) Major surgery unrelated to lung cancer within 4 weeks before enrollment, or not fully recovered from such surgery (diagnostic biopsies and peripherally inserted central catheter [PICC] placement are permitted); 4) Any known or suspected autoimmune disease, except: hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; stable type 1 diabetes mellitus with controlled blood glucose; Presence of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes mellitus, pulmonary fibrosis, acute pneumonia, etc.); 5) Receipt of live attenuated vaccine within 28 days before first dose, or planned receipt of live attenuated vaccine during the study period; 6)Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with detectable HBV-DNA (HBV-DNA testing required only for patients with negative HBsAg and positive HBcAb); positive hepatitis C virus (HCV) antibody with detectable HCV-RNA (HCV-RNA testing required only for patients with positive HCV antibody); autoimmune hepatitis; 7) Severe infection within 4 weeks before treatment, including but not limited to bacteremia or severe pneumonia requiring hospitalization; active infection of CTCAE grade =2 requiring systemic antibiotic therapy within 2 weeks before treatment, or unexplained fever >38.5°C during screening/before treatment (fever due to tumor cause may be allowed after investigator’s judgment); evidence of active tuberculosis infection within 1 year before treatment; 8) Prior or planned allogeneic bone marrow or solid organ transplantation; 9) Peripheral neuropathy >= grade 2; 10) Severe cardiac disease or conditions, including but not limited to: History of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmia (e.g., ventricular tachycardia), or high-grade atrioventricular block (i.e., Mobitz II second-degree or third-degree AV block); Coronary artery disease requiring anti-anginal medication; Clinically significant valvular heart disease; ECG evidence of transmural myocardial infarction; Poorly controlled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg). 3. Women who are pregnant or breastfeeding, women of childbearing potential with a positive pregnancy test at baseline, or women of childbearing potential unwilling to use effective contraception throughout the study period. 4. Documen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event, AE;OS;event-free survival;pathological complete response;R0 resection rate; | — |
Countries
China
Contacts
Public ContactYu Li
Shengjing Hospital of China Medical University
Outcome results
None listed