Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases

Inclusion Criteria

• •1. Aged 18 to 75 years, with an ECOG Performance Status of 0-2.
• •2. Histologically confirmed stage IV non-small cell lung cancer (NSCLC) or extensive-stage small cell lung cancer, with radiologically confirmed liver metastases (at least one measurable lesion with the longest diameter ≥ 1 cm).
• •3. Prior failure (due to progression or intolerance) to platinum-based doublet chemotherapy and PD-1/PD-L1 inhibitor therapy.
• •4. Adequate liver function reserve (Child-Pugh class A or B, ALT/AST ≤ 5 × ULN, total bilirubin ≤ 1.5 × ULN).
• •5. Life expectancy of at least 3 months.
• •6. Normal function of major organs and no severe dysfunction of the hematopoietic, cardiac, pulmonary, hepatic, renal, or bone marrow systems, or immunodeficiency diseases.
• •7. Within one week prior to enrollment, bone marrow and organ function meet the following criteria:Hemoglobin ≥ 80 g/L, neutrophil count ≥ 1.5 × 10⁹/L, and platelet count ≥ 70 × 10⁹/L. Renal function: Serum creatinine ≤ 1.5 × ULN, and endogenous creatinine clearance rate ≥ 55 ml/min.Liver function: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (if liver metastases are present, total bilirubin ≤ 3 × ULN and transaminases ≤ 5 × ULN are acceptable).
• •8. Voluntarily participates and provides written informed consent.
• •9. Good compliance and willingness to adhere to the study visit schedule and other protocol requirements.
• •10. Willingness to provide blood and tissue samples for biomarker testing.
• •11. Judged by the radiation oncologist to have no contraindications to liver radiotherapy. Patients who agree to receive immunotherapy, chemotherapy, and radiotherapy.
• •12. For patients of childbearing potential: agreement to use effective contraception during the study period and for at least 6 months after the last study treatment; negative serum or urine pregnancy test within 7 days prior to study entry; and not breastfeeding. Male patients with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.