small cell lung cancer
Conditions
Interventions
Experimental group:Treated with irinotecan liposome and tislelizumab combination regimen
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients have good compliance, can understand the research process of this study, and sign a written informed consent form; 2.Age= 18 years old; 3.Histologically or cytologically confirmed small cell lung cancer; 4.The clinical stage after imaging evaluation is extensive-stage small cell lung cancer; 5.At least one measurable lesion (according to RECIST1.1 criteria); 6.Failed first-line standard treatment within 6 months; 7.ECOG 0-1 points; 8.Expected survival time greater than 3 months; 9.Having appropriate organ function, defined as follows: (Within 14 days prior to enrollment, hematology and biochemistry tests must be completed, and the following conditions must be met) a. Absolute neutrophil count (ANC) =1.510^9/L b. Hemoglobin =90 g/dL c. Platelets (PLT) =10010^9/L d. Total bilirubin < upper limit of normal (ULN) e. Liver function indices (AST & ALT) in chemistry tests <2.5 times the upper limit of normal (ULN) (for patients with liver metastases, AST and ALT =5×ULN) f. Serum creatinine =1.2 mg/dL and creatinine clearance =50 mL/min (measured using 24-hour urine collection or calculated via the Cockroft-Gault method). 10.Non-pregnant or lactating women; Females/men of childbearing potential should take effective contraceptive measures during the study and within 6 months after the end of study treatment;
Exclusion criteria
Exclusion criteria: 1.Known history of severe allergy to any monoclonal antibody; Hypersensitivity to irinotecan or irinotecan liposomes or their excipients; 2.Diagnosed with pulmonary fibrosis or interstitial pneumonia within 28 days before enrollment; 3.Patients with symptomatic brain metastases; 4.Active infection: if HIV infection, chronic HBV/HCV is in the active stage (such as HBV DNA= 104 copy number or =2000IU/mL, antiviral hepatoprotective therapy is required first, and HBV DNA< 104 copy number or <2000IU/mL before enrollment, and continue to take antiviral drugs, monitor liver function and HBV viral load); 5.Combined with uncontrollable systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmias, history of severe pericardial disease and other cardiovascular diseases; Uncontrolled hypertension (defined as systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg after treatment with standardized antihypertensive drugs), or history of hypertension critical illness, hypertensive encephalopathy; uncontrollable diabetes (fasting blood glucose =10 mmol/L), etc.; 6.Active autoimmune disease (such as corticosteroids or immunosuppressive drugs) requiring systemic treatment in the past 2 years, and relevant replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency) is allowed; 7.Severe long-term diarrhea; 8.Severe mental illness. 9.Have participated in other clinical researchers within 4 weeks before enrollment; 10.Those who use strong inhibitors or inducers such as CYP3A4, CYP2C8 and UGT1A1; 11.Patients who are considered unsuitable to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1?Year Progression?Free Survival Rate;1?Year Overall Survival Rate;Adverse event;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactHualin Chen
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed