Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC

Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC:A Prospective, Single-center, Randomized, Open, Double-arm Clinical Trial

This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice.

Inclusion Criteria:

• Age more than 18 years old, regardless of gender;
• SCLC diagnosis based on histopathology according to the Primary Lung Cancer Diagnosis and Treatment Guidelines (2018 edition);
• TNM stage II-IV;
• ECOG PS score ≤2;
• Predicted survival time more than 3 months;
• Provision of signed informed consent.

Exclusion Criteria:

• Previous interventional therapies such as iodine seed implantation (within the past six months), ablation, BACE, or immunotherapy;
• Concurrent presence of other incurable malignant tumors;
• White blood cell count less than 3×10^9/L, neutrophil absolute count less than 1.5×10^9/L, neutrophil/lymphocyte ratio equal to or greater than 3, platelet count less than 50×10^9/L, hemoglobin concentration less than 90 g/L;
• Hepatic and renal insufficiency (creatinine level exceeding 176.8μmol/L); Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels more than twice the upper limit of normal;
• Uncorrectable coagulopathy or concurrent active hemoptysis;
• Complicated with active infection requiring antibiotic treatment;
• Uncontrolled hypertension, diabetes, or cardiovascular disease;
• Allergy to contrast agents;
• Women who are pregnant or lactating.