small cell lung cancer
Conditions
Interventions
group A:Atorvastatin+Irinotecan
group B:Irinotecan
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent prior to the implementation of any test related procedures; 2. =18 years old; 3. Histologically or cytologically confirmed small cell lung cancer (SCLC); 4. Extensive small-cell Lung cancer (ED-SCLC) according to the Veterans Administration Lung Study Group (VALG); 5. According to the solid tumor efficacy evaluation criteria (RECIST Version 1.1), there was at least one radiographically measurable lesion. 6. ED-SCLC patients who have previously received standard first-line chemotherapy (except irinotecan) have failed; 7. ECOG score 0-1; 8. Expected survival time >3 months; 9. Adequate organ function; 10. Female subjects of childbearing age should receive urine or serum Pregnancy test within 3 days before receiving the first study drug administration (the first day of the first cycle) and the result is negative. If the urine Pregnancy test result cannot be confirmed as negative, a blood Pregnancy test is required. Women of non childbearing age are defined as at least one year after menopause, or having undergone surgical sterilization or Hysterectomy; 11. If there is a risk of conception, all subjects (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last study drug administration (or 180 days after the last study drug administration).
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed mixed SCLC and NSCLC; 2. Malignant diseases other than SCLC diagnosed within 5 years prior to initial administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical excision); 3. Active liver disease may include unexplained persistent elevations of liver aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT). 4. Currently participating in an interventional clinical study, or receiving other investigational drugs or using investigational devices within 4 weeks prior to initial dosing; 5. Active brain metastasis or meningeal metastasis.Treated subjects with BMS were required to meet the following criteria to be enrolled: asymptomatic;No radiographic evidence of progress =4 weeks after treatment completion;Completion of treatment =7 days before the first dose of study drug;Systemic corticosteroid therapy (> 10mg/ day prednisone or equivalent) was not required =14 days before the first dose of the study drug;If imaging during the screening period reveals a new asymptomatic BMS in the patient, radiotherapy and/or surgery are required.If all other criteria are met after treatment, no additional brain scans are required before randomization. 6. Radiotherapy: The completion time of radiotherapy for brain and palliative radiotherapy for bone lesions was less than 7 days before the first dose of the study drug. 7. Clinically uncontrollable pleural effusion/abdominal effusion (subjects with no need to drain effusion or no significant increase in effusion after 3 days of stopping drainage can be enrolled); 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Those who are known to be allergic to the active ingredient or excipients of the drug in this study; 10. Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., = grade 1 or baseline, excluding weakness or hair loss); 11. Untreated active hepatitis B (defined as HBsAg positive coupled with a detected HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center); 12. Other conditions deemed unsuitable for inclusion by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Overall survival,OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;disease control rate,DCR;duration of response,DOR;Progression-Free Survival,PFS; | — |
Countries
China
Contacts
Public ContactWenfeng Li
The first Affiliated Hospital of Wenzhou Medicine University
Outcome results
None listed