| Eligibility |
Inclusion Criteria:
- 1.Male or female patients aged 18 to 70 years (18 years and 70 years are inclusive).
2.Histologically or cytologically confirmed extensive small cell lung cancer.
3.Disease progression or recurrence after one prior systematic anti-tumor treatment
regimen (including platinum-containing chemotherapy, etc.; with or without
radiotherapy).
4.The patient should have at least one measurable lesion (according to RECIST 1.1
criteria).
5.Life expectancy =3 months. 6.The Eastern Cooperative Oncology Group (ECOG)
performance status score is between 0 to 1 point.
7.Laboratory results during screening:
- Hematology:Absolute neutrophil count = 1.5× 109/L, platelet count= 100× 109/L and
hemoglobin= 90 g/L.
- Liver function: Total bilirubin <1.5×upper limit of normal (ULN), alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN for the
subjects without liver metastasis; ALT and AST=5×ULN for the subjects with liver
metastasis.
- Kidney function: Serum creatinine = 1.5 ×ULN or creatinine clearance rate = 50
mL/min.
- Coagulative function: Prothrombin time - international standardized ratio(PT-INR)
<1.5.
8.The subject has voluntarily signed the written informed consent form (ICF) and
can comply with the study protocol.
9.The female subjects and male subjects of childbearing age and the partners of
the male subjects agree to take reliable contraceptive measures (such as
abstinence, sterilizing operation, contraceptives, injection of the contraceptive
drug medroxyprogesterone acetate or subdermal implant of contraceptives) during
the study period and within 6 months after infusion of the study drugs.
Exclusion Criteria:
- 1.Patients with the symptomatic brain metastasis, meningeal metastases, spinal cord
tumor invasion, spinal cord compression. Patients with superior vena cava syndrome,
obstructive atelectasis and bone metastasis who have local symptoms, which may require
radiotherapy / surgery / endoscopic treatment / interventional treatment and other
non-medical treatment.
2.Patients have other malignant tumors within 5 years(except for cured stage ?B or
lower cervical cancer, non-invasive basal cell or squamous cell skin cancer)
3.Uncontrolled massive hydrothorax, ascites and pericardial effusion. 4.Patients have
history of deep vein thrombosis or pulmonary embolism. 5.The patient with persistent
or active infection signs which need intravenous injection of antibiotics.
6.Medical history of the following diseases within 6 months: myocardial infarction,
unstable angina pectoris, coronary revascularization, cardiac dysfunction (New York
heart association (NYHA) grade = II), severe unstable ventricular arrhythmia or
arrhythmias that need to be treated at the time of screening.
7.The patient with Active hepatitis B: hepatitis B surface antigen (HBsAg) positive
and the peripheral blood hepatitis B virus DNA (HBV DNA)titer =1× 103 copies/mL or 200
IU/ml. The subject is eligible to be enrolled if HBsAg is positive and peripheral
blood HBV DNA titer <1×103 copies/mL or 200 IU/ml and the investigator considers that
the subject is at the stable stage of chronic hepatitis and the risk will not be
increased for the subject. The patient with hepatitis C virus (HCV) antibody positive,
human immunodeficiency virus (HIV) antibody positive and active syphilis infection.
8.Patients have severe gastrointestinal disorders (such as gastrointestinal bleeding,
infection, chronic enteritis, obstruction, or diarrhea with CTCAE grade 1 or higher)
at the time of screening.
9.Patients with medical history of neuropathy or mental disorder (including epilepsy
or dementia).
10.Patients have been or are suffering from bronchial asthma, interstitial lung
disease or active hemoptysis within 6 months.
11.Patients with primary diseases of other major organs (such as nervous system,
cardiovascular system, urinary system, digestive system, respiratory system or
metabolic endocrine system) and the investigators believe that it is not suitable for
enrollment, or for other reasons the investigators don't think that suitable for
inclusion.
12.Patients who have previous treatment with irinotecan or immunotherapy. 13.Known
hypersensitivity to any of the components of irinotecan liposome injection, other
structurally similar compounds (such as camptothecins), or other liposomal products.
14.Patients have participated in other pharmaceutical clinical trial within one month
before screening.
15.Patients have received systemic antitumor therapy such as radiation, chemotherapy,
immunotherapy or other treatments within 4 weeks prior to start of therapy.
16.Patients have received live or attenuated vaccines within one month prior to the
screening.
17.Use of strong CYP3A4 inducers (phenytoin or carbamazepine, barbiturates, rifampin,
rifabutin or rifapentine, hypericum perforatum, etc) during or within 14 days prior to
starting study medication.
18.Use of strong CYP3A4 inhibitors (clarithromycin, ketoconazole or itraconazole,
indinavir, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir,
telaprevir,voriconazole, etc) during or within 14 days prior to starting study
medication. 19.Use of strong UGT1A1 inhibitors during or within 14 days prior to
starting study medication (atazanavir, gemfibrozil, indinavir, etc.).
20.Patients who are taking or may take drugs that reduce cholinesterase activity or
choline drugs (neostigmine, lissamine, acetylcholine, etc.).
21.Patients may used the skeletal muscle relaxation drugs (such as succinylcholine)
during the trial.
22.The patient who has drug and/or alcohol abuse. 23.Pregnant or lactating women.
24.Patients who did not take contraceptive measures during the trial. 25.Other
circumstances which are considered by the investigator that the subject is unsuitable
to be enrolled.
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