Small cell lung cancer
Conditions
Interventions
Patients with small cell lung cancer and liver metastasis:Radiotherapy in combination with immunotherapy (PD-1/PD-L1 inhibitors) and chemotherapy.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, with an ECOG PS 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 metastasis (>=1 measurable lesion with the longest diameter >=1 cm); 3. Previous treatment with platinum-based doublet chemotherapy and PD-1 inhibitor therapy failed (due to disease progression or intolerance); 4. Adequate liver function reserve (Child-Pugh class A or B, ALT/AST =3 months; 6. Normal function of major organs, without severe dysfunction of the blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency diseases; 7. Within one week prior to enrollment, the patient's bone marrow, liver, and kidney functions meet the following criteria:Hemoglobin >=80 g/L, neutrophils >=1.5×10?/L, and platelets >=70×10?/L;Renal function: Cr =55 ml/min;Liver function: total bilirubin <= ULN × 1.5; ALT, AST <= ULN × 2.5 (in cases of liver metastasis, total bilirubin <= ULN × 3, transaminases <= ULN × 5); 8. The patient voluntarily participates and signs the informed consent form; 9. Signed informed consent form with good compliance; 10. Agreement to provide blood and tissue samples for biomarker testing; 11. Patients judged by the radiotherapy physician to have no contraindications for liver radiotherapy; patients who agree to receive immunotherapy, chemotherapy, and radiotherapy; 12. Female patients of childbearing potential agree to use contraception during the study and for 6 months after the study; patients with a negative serum or urine pregnancy test within 7 days prior to study entry and who are not breastfeeding; male patients who agree to use contraception during the study and for 6 months after the study.
Exclusion criteria
Exclusion criteria: 1. History of any active autoimmune disease or autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [may be included after hormone replacement therapy]); prior hepatic radiotherapy or liver transplantation; history of liver cirrhosis (Fibroscan >= F3), portal hypertension, or hepatic encephalopathy; 2. 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 hepatitis B and hepatitis C; 3. Uncontrolled cardiac clinical symptoms or diseases, such as (a) NYHA Class II or above heart failure, (b) unstable angina, (c) myocardial infarction within the past year, (d) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 4. Severe infection or serious comorbidities within 4 weeks prior to the first dose; 5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6. History of or concurrent malignancies of other systems within the past 5 years; 7. Known allergy to any of the investigational drugs; 8. Pregnant or lactating women, or subjects of reproductive potential unwilling to use effective contraception; 9. Child-Pugh Class B or C hepatic impairment; 10. Other contraindications as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;safety; | — |
Countries
China
Contacts
Public ContactWeigang Xiu
West China Hospital of Sichuan University
Outcome results
None listed