This is clinical trial evaluating the safety and efficacy of radiotherapy combined with immunotherapy and chemotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) and liver metastases.
Aged 18 to 75 years, with an ECOG Performance Status of 0-2.
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).
Prior failure (due to progression or intolerance) to platinum-based doublet chemotherapy and PD-1/PD-L1 inhibitor therapy.
Adequate liver function reserve (Child-Pugh class A or B, ALT/AST ≤ 5 × ULN, total bilirubin ≤ 1.5 × ULN).
Presence of any active autoimmune disease or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [may be included if controlled with hormone replacement therapy]); prior liver radiotherapy or liver transplantation; history of liver cirrhosis (Fibroscan ≥ F3), portal hypertension, or hepatic encephalopathy.
Congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive HCV antibody and HCV RNA above the lower limit of detection of the assay), or co-infection with both hepatitis B and C.
Uncontrolled or significant cardiac disease, including: (a) NYHA Class II or higher heart failure; (b) Unstable angina; (c) Myocardial infarction within the past 1 year; (d) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
Severe infection or serious comorbidities within 4 weeks prior to the first dose of study treatment.
Single group
Immunotherapy
DrugCombined With Chemotherapy( (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) ). Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) or low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) ) followed by Immunotherapy
Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin)
DrugCombined With immunotherapy.
low-dose radiation
RadiationLiver-directed radiotherapy (low-dose radiation(3Gy\*5d) followed by Immunotherapy
Stereotactic Body Radiation Therapy (SBRT)
Radiationlow-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) )
ORR
The proportion of participants who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator.
Progression-Free Survival (PFS)
The time from the date of enrollment until the first documented date of disease progression as per RECIST v1.1, or death from any cause, whichever occurs first.
Disease Control Rate (DCR)
The proportion of participants who achieve a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1.
Incidence of Adverse Events (AEs)
The number and percentage of participants with any adverse event, serious adverse event, and immune-related adverse event. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
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