Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

Exclusion Criteria

• •1. Pathological diagnosis of compound small cell lung cancer;
• •2. Patients with meningeal metastasis, spinal cord tumor invasion, spinal cord compression syndrome;
• •3. Superior vena cava syndrome with symptoms or significantly aggravated imaging, which may require radiotherapy/surgery/endoscopic therapy/intervention and other non-medical treatment; the presence of large amount of pleural effusion, ascites and/or pericardial effusion with local treatment and unstable control;
• •4. Active infection (including tuberculosis infection) requiring systemic anti-bacterial, antifungal, antiviral and other treatments during screening;
• •5. Recurrent symptomatic poorly controlled chronic obstructive pulmonary disease, extensive interstitial lung disease (including interstitial pneumonia, pulmonary interstitial fibrosis, etc.) at screening,
• •6. Extensive radiation pneumonitis, pulmonary embolism or active massive hemoptysis; Patients with severe gastrointestinal diseases or gastrointestinal disorders (such as gastrointestinal bleeding, gastrointestinal obstruction, unhealed peptic ulcer, immune enteritis, ulcerative colitis, Crohn's disease, ischemic necrotizing enteritis, diarrhea \> grade 1, other gastrointestinal diseases that may affect the tolerance of chemotherapy) at screening;
• •7. Patients with the following cardiovascular and cerebrovascular diseases or history:
• •1. patients with unstable hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or a history of hypertensive crisis or hypertensive encephalopathy;
• •2. patients with unstable severe arrhythmia;
• •3. patients with the following cardiovascular and cerebrovascular diseases within 6 months: myocardial infarction, unstable angina, coronary revascularization/angioplasty, coronary artery bypass grafting, coronary artery stenting, New York Heart Association (NYHA) class ≥ 2 cardiac insufficiency, severe unstable arrhythmia, deep vein thrombosis, pulmonary embolism history, active cerebral infarction, active cerebral hemorrhage;
• •8. Patients with any of the following conditions:
• •1. positive hepatitis B virus surface antigen (HBsAg) test,And peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) detection ≥ 1000 IU/mL;
• •2. hepatitis C virus antibody (HCV-Ab) positive, and hepatitis C virus ribonucleic acid (HCV-RNA) detection ≥ 100 IU/mL;
• •3. human immunodeficiency virus antibody (HIV-Ab) detection positive;
• •9. Other malignancies within 5 years before screening (except cured stage IB or lower cervical cancer, non-invasive basal cell, scale-cell skin cancer or resectable carcinoma in situ);
• •10. Patients with primary diseases of other important organs (such as nervous system, cardiovascular and cerebrovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system diseases) and the researchers believe that it is not suitable for participants, or for other reasons the researchers believe that it is not suitable for participants;
• •11. Previous treatment with irinotecan or irinotecan modified, topotecan or other topoisomerase I inhibitors;
• •12. Known hypersensitivity to irinotecan hydrochloride liposomes or its excipients, structurally similar compounds (such as camptothecin compounds), other liposomal drugs, and topotecan;
• •13. Those who have been vaccinated with live vaccine or live attenuated vaccine before screening;
• •14. Patients who have received systemic anti-tumor therapy in 4 weeks before randomization;
• •15. Patients who have applied other clinical trial drugs/devices before randomization;
• •16. Patients who have used strong inducers or strong inhibitors of CYP3A4 and strong inhibitors of UGT1A1 before randomization;
• •17. Adverse reactions caused by previous anti-tumor treatment are not recovered to grade 1 or lower (except alopecia and peripheral neuropathy);
• •18. History of drug abuse, drug abuse and/or alcoholism;
• •19. Pregnant or lactating women;
• •20. Other conditions (including but not limited to unstable nervous system diseases and mental disorders) that are considered unsuitable for inclusion in this trial by the investigator.