Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial

Exclusion Criteria

• •1. Central nervous system metastasis.
• •2. History of any active autoimmune disease or autoimmune disease (including but not limited to moderate or severe interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \[patients controlled by hormone replacement therapy may be included\]); patients with vitiligo or childhood asthma completely resolved without adult intervention may be included; patients requiring bronchodilators for medical intervention are excluded.
• •3. Congenital or acquired immunodeficiency, such as HIV infection, active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection by analytical methods), or co-infection of hepatitis B and C, active pulmonary tuberculosis.
• •4. Use of immunosuppressive drugs within 14 days prior to the first administration of the study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg/day of prednisone or its equivalent).
• •5. Vaccination with live attenuated vaccines within 4 weeks before the first administration or planned during the study period.
• •6. Any other malignancy within the past 3 years.
• •7. Evidence of past or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, or severely impaired lung function.
• •8. Uncontrolled hypertension.
• •9. Grade II or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥450 ms for males and ≥470 ms for females). According to NYHA standards, Class III-IV heart failure, or left ventricular ejection fraction (LVEF) \< 50% by cardiac ultrasound, myocardial infarction within 6 months before enrollment, NYHA Class II or higher heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or electrocardiogram (ECG) indicating acute ischemia or active conduction system abnormalities.
• •10. Severe infection within 4 weeks before the first administration (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever \> 38.5°C during screening/first administration.
• •11. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• •12. Pregnant or breastfeeding women; patients of childbearing potential unwilling or unable to use effective contraception.
• •13. Known allergic reaction, hypersensitivity, or intolerance to SHR-1316, etoposide, cisplatin, or their excipients.
• •14. Participation in another clinical study or less than 4 weeks since the end (last dose) of a previous clinical study, or less than 5 half-lives of the study drug.
• •15. Known history of substance abuse, alcohol abuse, or drug addiction.
• •16. Any condition that the investigator believes may compromise the safety of the participant or the participant's ability to meet or follow study requirements.