| Eligibility |
Inclusion Criteria:
1. Aged 18-75 years old, both men and women are welcome;
2. Extensive-stage small cell lung cancer confirmed by histology or cytology (staging
according to the American Veterans Lung Cancer Association, VALG);
3. Patients whose induction therapy must receive the first-line standard treatment
regimen of PD-L1 monoclonal antibody combined with chemotherapy, and whose efficacy
evaluation is CR, PR or SD (according to RECIST 1.1); patients who have previously
undergone surgical treatment and receive curative adjuvant therapy such as
radiotherapy , chemotherapy patients, there is a treatment-free interval of at least 6
months from the last chemotherapy, radiotherapy or chemoradiotherapy to the diagnosis
of extensive-stage SCLC;
4. Expected survival time =12 weeks;
5. ECOG physical status score 0~1 points;
6. Before the first dose of study drug, laboratory test values must meet the following
conditions:
1. Blood routine (no blood transfusion or correction with hematopoietic stimulating
factor drugs within 14 days before screening): WBC =3.0 × 109/L; ANC =1.5 ×
109/L; PLT =100 × 109/L; HGB =90 g/L;
2. Liver function: AST =2.5 × ULN in subjects without liver metastasis; ALT =2.5 ×
ULN; ALT and AST in subjects with liver metastasis =5 × ULN; TBIL =1.5 × ULN;
3. Renal function: serum Cr =1.5 × ULN or CrCl =50 mL/min (using Cockcroft/Gault
formula);
4. Coagulation function: INR =1.5 × ULN, APTT =1.5 × ULN (only applicable to
patients who are not currently receiving anticoagulation therapy);
7. Women of childbearing age must have a serum pregnancy test within 7 days before taking
the drug for the first time, and the result is negative. Female subjects of
childbearing age and male subjects whose partners are women of childbearing age must
agree to use contraception within 24 weeks from signing the informed consent form to
the last administration of the study drug;
8. The subjects voluntarily joined this study, signed the informed consent form, had good
compliance, and cooperated with the follow-up.
Exclusion Criteria:
1. Patients transformed from non-small cell carcinoma (NSCLC) to SCLC or SCLC with mixed
histology;
2. Meningeal metastasis or symptomatic central nervous system metastasis; for patients
with asymptomatic brain metastasis or stable symptoms for = 2 weeks after treatment of
brain metastasis, they can participate in this study as long as they meet all the
following criteria: Outside the central nervous system Have measurable lesions, no
metastasis to the meninges, midbrain, pons, cerebellum, medulla oblongata or spinal
cord, no previous history of intracranial hemorrhage, and stop hormone therapy 14 days
before the first dose of study drug;
3. Third space effusion with clinical symptoms requires repeated drainage, such as
pericardial effusion, pleural effusion and peritoneal effusion that cannot be
controlled by pumping or other treatments;
4. Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as
bronchiolitis obliterans), drug-induced pneumonia, infectious pneumonia, radiation
pneumonitis requiring steroid treatment, active tuberculosis, or other serious effects
on the lungs Functional moderate to severe lung disease;
5. There is an active autoimmune disease and corticosteroids (>10 mg/day prednisone or
equivalent dose) or other immunosuppressants are used within 14 days before the first
medication;
6. Have serious cardiovascular diseases, such as New York Heart Association (NYHA) grade
2 or above heart failure, unstable angina, unstable arrhythmia, and myocardial
infarction occurring within 3 months before enrollment or cerebrovascular accident;
7. Other malignant tumors =5 years before the first dose of medication (fully treated
cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer,
localized prostate cancer after radical surgery, and ductal carcinoma in situ after
radical surgery can be admitted) group and allows hormone therapy for non-metastatic
prostate or breast cancer);
8. Hypertension that cannot be controlled by oral antihypertensive drugs (systolic blood
pressure ?140mmHg or diastolic blood pressure ?90mmHg);
9. Urine routine shows urine protein =++ and confirms that the 24-hour urine protein
quantification is >1.0 g;
10. Risk of bleeding: Have clinically significant bleeding symptoms or clear bleeding
tendency within 3 months before enrollment, such as gastrointestinal bleeding,
bleeding gastric ulcer, etc.; suffer from hereditary or acquired bleeding diseases or
coagulation Functional disorders, such as aplastic anemia, etc.; taking anticoagulant
or antiplatelet drugs (such as warfarin, phenprocoumon);
11. Those who have recently experienced intestinal obstruction or gastrointestinal
perforation (within 3 months); or those who are unable to swallow tablets normally,
which may affect drug absorption as judged by the researcher;
12. People with the following infectious diseases are not allowed to join the group:
1. HBsAg is positive and the HBV DNA copy number is greater than the upper limit of
normal value (1000 copies/ml or 500IU/ml) in the laboratory of the research
center;
2. HCV positive (HCV RNA or HCV Ab detection indicates acute or chronic infection);
3. Known history of HIV positivity or known acquired immunodeficiency syndrome;
13. Have undergone major surgery within 28 days before the screening period, or plan to
undergo major surgery during the study period;
14. Have received systemic immunosuppressive drug treatment (including but not limited to
glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide and
anti-tumor necrosis factor [anti-tumor necrosis factor] within 1 week before the first
medication) TNF] drugs). Patients receiving short-term, systemic immunosuppressive
therapy, such as glucocorticoids for nausea, vomiting, or allergic reaction management
or prophylaxis, may be enrolled in the study after approval by the investigator;
15. Live attenuated vaccines are used within 28 days before the first dose, or live
attenuated vaccines are expected to be needed during the study;
16. Known to be allergic to study drugs or excipients, known to have severe allergic
reactions to any monoclonal antibody drug;
17. Have received any other experimental drug treatment or participated in another
interventional clinical study within 4 weeks before the first use of the drug;
18. Patients who have previously received allogeneic bone marrow transplantation or solid
organ transplantation;
19. According to the researcher's judgment, the subject has other factors that may lead to
the forced termination of this study, such as non-compliance with the protocol, other
serious diseases (including mental illness) that require combined treatment, and
family or social factors that may affect the study. to the safety of subjects or the
collection of information and samples
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