small cell lung cancer
Conditions
Interventions
single arm:Irinotecan liposomes combined with loplatin
Sponsors
The Fourth Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) The patient had good compliance, could understand the research process of the study, and signed a written informed consent; (2) Age 18-80 (including 18 and 80 years old); (3) Histologically or cytologically confirmed small cell lung cancer; (4) The presence of at least one measurable lesion according to RECIST 1.1 for solid tumors; (5) Patients who have failed first-line treatment; (6) ECOG score 0-2; (7) The expected survival time is greater than 3 months; (8) Adequate organ function, as defined below :a. Absolute neutrophil count (ANC) =1.5*109/L; b. Hemoglobin =90g/dL; c. Platelets (PLT) =100*109/L; d. Total bilirubin < upper limit of normal (ULN); e. Chemical examination of liver function index (AST&ALT) <2.5 times the upper limit of normal value (ULN) (AST and ALT =5×ULN in patients with liver metastasis); f. Serum creatinine =1.2mg/dL and creatinine clearance =50mL/min (urine collected for 24 hours or calculated using the Cockroft-Gault method). (9) Non-pregnant or lactating women; Effective contraception should be used by women/men of reproductive age during the study period and for 6 months after the end of study treatment;
Exclusion criteria
Exclusion criteria: (1) Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment; (2) systemic treatment of active, uncontrolled bacterial, viral, or fungal infections, defined as persistent signs/symptoms associated with the infection that do not go away despite the use of appropriate antibiotics, antiviral therapy, and/or other treatment, including patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); (3) There are serious concomitant diseases, such as diabetes and can not be well controlled by hypoglycemic drugs, clinically serious (that is, active) heart disease, renal failure, liver failure, uncontrolled epilepsy, central nervous system disease or history of mental disorders, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, etc.; (4) Severe diarrhea (= grade 2); (5) Known allergy to irinotecan liposomes and lobaplatin related components; (6) Had participated in other clinical investigators within 4 weeks before enrollment; (7) Patients deemed unsuitable for this trial by the investigator. (8) Had active brain metastases;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYuan Mao
The Fourth Affiliated Hospital of Nanjing Medical University
Outcome results
None listed