Study of Irinotecan Liposome Combined With Anlotinib as Second-line Regimen in Patients With Small Cell Lung Cancer
This study is a single arm, multi-center, prospective clinical trial. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan combined with anlotinib hydrochloride for relapsed small-cell lung cancer, who have progressed on or less than 6 month after platinum-based first-line therapy.
• 1\) Aged ≥18 and ≤75 years old;
• 2\) Histologically or cytologically confirmed small cell lung cancer;
• 3\) At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;
• 4\) Radiologically confirmed recurrence or progression within 6months after platinum-based, first-line chemotherapy or chemoradiation therapy;
• 5\) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• 6\) Expected survival of more than 3 months;
• 7\) Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to no more than Grade 1 of CTCAE 5.0 criteria or baseline, with the exception of alopecia or other toxicity without safety concerns by the investigators' judgment);
• 8\) Adequate major organ function, patients should meet the following criteria:
• ① Bone marrow function: absolute neutrophile count (ANC)≥1.5×109/L，platelet (PLT)≥100×109/L, hemoglobin (Hb)≥90g/L, white blood cell (WBC)≥3.0×109/L；
• ② Hepatic function: total bilirubin≤1.5×upper limit of normal value(ULN)；ALT and AST≤2.5×ULN，liver metastasis：≤5×ULN；
• ③ Renal function: serum creatinine ≤1.5×ULN and creatinine clearance rate ≥60 mL/min;
• ④ Coagulation function：Activated partial thromboplastin time(APTT)、International normalized ratio(INR)、prothrombin time (PT)≤1.5×ULN；
• ⑤ urine routines show urine protein \< 2+(when urine protein \>2+, urine protein quantity\< 1.0 g during 24 hours before 7 days);
• 9\) Patients fully understood and volunteered to participate in the study.