Lung cancer
Conditions
Interventions
Treatment group:Receiving radiotherapy and subcutaneous injection of the PCSK9 inhibitor evolocumab 420 mg once a month (or 140 mg once every 2 weeks)
Sponsors
Xi'an Jiaotong University Second Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with either locally advanced (stage IIIB-IIIC) or metastatic non-small cell lung cancer (NSCLC), and those with limited-stage small cell lung cancer (SCLC). 2.According to the efficacy evaluation criteria for Solid tumors (RECIST Version 1.1), there is at least one measurable lesion. The measurable lesion has not received local treatments such as radiotherapy; 3.Age >=18, male or female; 4.The ECOG PS score is 0 to 2 points. The expected survival period is >=6 months; 5.It has sufficient organ and bone marrow functions; (1) Blood routine examination criteria:1). Hemoglobin (HB) content >=90g/L (no blood transfusion within 28 days); 2). Absolute neutrophil count (ANC) >=1.5×10^9/L; 3). Platelet count (PLT) >=80×10^9/L; 4). White blood cell count (WBC) >=3.5×10^9/L; (2) Biochemical examination must meet the following criteria: 1). Creatinine (Cr) =60ml/min (Cockcroft-Gault formula); (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >=lower limit of normal (50%); (4) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN
Exclusion criteria
Exclusion criteria: 1.Patients with hypocholesterolemia, hypolipidemia and their family history, or those who have previously been allergic to subcutaneous injection of pcsk9 inhibitors or oral atorvastatin; 2.Had undergone major surgical operations (craniotomy, thoracotomy or laparotomy) within 4 weeks before the first dose study or was expected to undergo major surgery during the study treatment; 3.Patients with any severe and/uncontrolled diseases, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure 150 mmHg or diastolic blood pressure 100 mmHg); Myocardial infarction that occurred less than 6 months before enrollment, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia or drug-uncontrollable heart failure, CAD patients who have recently undergone surgery and/or stent therapy, if stable and without symptomatic angina pectoris, active ischemia meets the condition (2) Active or uncontrolled severe infections (2 points on the Rapid Sequential Organ Failure Assessment (q SOFA)); (3) Liver diseases such as liver cirrhosis (Child-Pugh classification standard reaching grade B and C), decompensated liver diseases, and chronic active hepatitis; (4) Poor control of diabetes (fasting blood glucose (FBG)) 10mmol/L); (5) Urine routine test indicates urine protein, and 24-hour urine protein quantification is confirmed. 1.0g; (6) Known to have active pulmonary tuberculosis; (7) Screening for pre-existing or clinically significant central nervous system diseases, such as epilepsy, epileptic seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndrome or mental disorders; 4.Patients whose imaging shows that the tumor has invaded the periphery of important blood vessels or whose researchers determine that the tumor is highly likely to invade important blood vessels and cause fatal massive hemorrhage during the subsequent study period; 5.Those with multiple factors that affect the absorption of oral drugs (such as after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 6.Those with a history of immunodeficiency, including a positive HIV test or having other acquired congenital immunodeficiency diseases, or a history of organ transplantation; According to the researchers' judgment, patients with any factors that affect the compliance of the plan, including uncontrollable medical, psychological, family, sociological or geographical conditions, etc; 7.Patients with any medical, psychological, familial, sociological, or geographical condition that, in the investigator's judgment, could compromise protocol compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Remission Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS);Blood lipid level;Progression Free Survival(PFS);Safety and adverse reaction;Inflammatory factor;Immune cell subsets;Changes in myocardial enzyme spectrum and electrocardiogram; | — |
Countries
China
Contacts
Public ContactXixi Zhao
Xi'an Jiaotong University Second Affiliated Hospital
Outcome results
None listed