Lung cancer
Conditions
Interventions
Test group:Treatment of suofetinib combined with vinorelbine
Sponsors
Anhui Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up; 2. Retreated patients with advanced lung cancer diagnosed by histopathology or cytology; 3. Advanced lung cancer patients who progress or cannot tolerate treatment after receiving at least one systematic treatment regimen in with second-line and more; 4. Neuroendocrine differentiation markers(IHC) syn, CGA and CD56 were positive in at least one item or blood NSE level >= 15.2ng/ml; 5. Age 18-75 years old (including boundary value), both men and women; ECoG score: 0-1; Expected survival >= 12 weeks; 6. Patients with non-small cell lung cancer with negative results of EGFR, ALK and ros1 genes; Or patients with positive test results and drug resistance or intolerance after receiving relevant targeted drug treatment; 7. At least one measurable lesion (according to RECIST 1.1 standard); The diameter of the target lesion was accurately measured by magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement, and the target lesion had not received local treatment before (including but not limited to HAIC, radiofrequency ablation, argon helium knife, radiotherapy and other local treatment methods); 8. The functions of main organs and bone marrow were basically normal: (1) Blood routine: leukocyte >= 4.0*10^9/L, neutrophil >= 1.5*10^9/L, platelet >= 100*10^9/L, hemoglobin >= 90g/L; (2) International standardization ratio (INR) = 60ml/min; (5) Normal cardiac function, left ventricular ejection fraction (LVEF) >= 50% detected by two-dimensional echocardiography; 9. Those who have received systematic, radical brain or meningeal metastasis treatment (radiotherapy or surgery) in the past, and have been stable for at least 1 month if confirmed by imaging, and have no clinical symptoms can be included; 10. Male or female patients with fertility voluntarily use effective contraceptive methods during the study period and within 6 months of the last study, such as double barrier contraceptives, condoms, oral or injection contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless they have natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Patients who have previously used sofatinib; 2. Previous use of other targeted drugs (such as bevacizumab, endu, etc.); 3. Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment; 4. Other malignant tumors in the past 5 years, except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix after radical surgery; 5. Patients with brain metastases with symptoms or symptom control time less than 2 months; 6. The patient currently has any disease or condition that affects drug absorption, or the patient cannot take sofatinib orally; 7. Any operation (except biopsy) or invasive treatment or operation was performed within 4 weeks before enrollment, and the surgical incision was not completely healed (except venous catheterization, puncture and drainage, etc.); 8. The researchers judged clinically significant electrolyte abnormalities; 9. The patient currently has hypertension that cannot be controlled by drugs, which is specified as systolic blood pressure = 140 mmHg and / or diastolic blood pressure >= 90 mmHg; 10. Urine routine showed that urinary protein >= 2 +, and 24-hour urinary protein > 1.0g; 11. International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5*ULN; 12. At present, the patient has gastrointestinal diseases such as gastric and duodenal active ulcer and ulcerative colitis, or active bleeding of unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation determined by the researcher; 13. Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment (bleeding > 30 ml within 3 months, hematemesis, black stool and bloody stool), hemoptysis (fresh blood > 5 ml within 4 weeks) or thromboembolism events within 12 months (including stroke events and / or transient ischemic attack); 14. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure New York Heart Association (NYHA) grade > 2; Ventricular arrhythmias requiring drug treatment; ECG showed QT c interval >= 480 MS; 15. Unrelieved toxic reactions higher than CTCAE grade 2 (CTCAE V5.0) caused by any previous anti-cancer treatment, excluding hair loss and lymphopenia; 16. Any other disease, clinically significant metabolic abnormality, physical examination abnormality or laboratory examination abnormality, according to the judgment of the investigator, there is reason to suspect that the patient has a disease or state that is not consistent with the use of the study drug (such as having seizures and requiring treatment), or will affect the interpretation of the study results, or put the patient in a high-risk situation; 17. Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis [people known to be hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e. HBV DNA positive (> 1*10^4 copies/ml or > 2000 IU/ml); Hepatitis C virus infection (HCV) is known and HCV RNA is positive (> 1*10^3 copies/ml), or other hepatitis, cirrhosis]; 18. According to the judgment of the researcher, the patient has other factors that may affect the research results or cause the forced termination of this study, such as alcoholism,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression free survival;Disease control rate;Objective remission rate;Overall survival;Quality of life; | — |
Countries
China
Contacts
Public ContactMei Chai
Anhui Chest Hospital
Outcome results
None listed