Advanced non-squamous non-small cell lung cancer
Conditions
Interventions
A+T:A+T
Gefitinib + Anlotinib + Metformin combination therapy:Gefitinib + Anlotinib + Metformin combination therapy
Gefitinib + Anlotinib + Metformin combination therapy (Patients with type 2 diabetes requiring oral metformin):Gefitinib + Anlotinib + Metformin
Sponsors
The First Affiliated Hospital of Xinxiang Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects were 18-75 years old when they signed the informed consent form, both male and female. 2. Diagnosed by histopathology as lung adenocarcinoma (mixed component = 90g/L (no blood transfusion within 28 days); (2) ANC >= 1.5 x 10^9/L; (3) PLT >= 100 x 10^9/L. 6.2 The biochemical inspection shall meet the following standards: (1) TBIL = 30g/L (5) Cr = 60ml/min; (6) ATPP = the lower limit of normal (50%). 7. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy tests are negative within 7 days before the study is enrolled , And must be non-lactating patients; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period. 8. The patient voluntarily joined the study, signed an informed consent form, and had good compliance
Exclusion criteria
Exclusion criteria: Exclusion criteria for target diseases 1. Subjects with other histopathological types of non-small cell lung cancer; 2. Subjects with EGFR mutation or ALK positive; 3. Those without measurable lesions; 4. Patients with cancerous meningitis and spinal cord compression; 5. Active central nervous system (CNS) metastases; CNS metastases are clinically stable after adequate treatment and maintained for at least 4 weeks, can participate in the group. Medical history and complications 1. Those who have multiple factors that affect oral medications (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction, etc.); 2. 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); patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval >= 480ms) and grade I cardiac function Incomplete (2) Active or uncontrolled severe infection, active tuberculosis; (3) Liver diseases such as liver cirrhosis, decompensated liver disease, chronic active hepatitis; (4) Diabetes is poorly controlled (fasting blood glucose (FBG) > 10mmol/L); (5) Urine routine test showed that urine protein was >= ++, and the 24-hour urine protein was confirmed to be more than 1.0 g. 3. Those who received major surgery within 4 weeks before the first medication; those who received non-thoracic radiotherapy> 30 Gy within 4 weeks before the first medication, those who received chest radiotherapy> 30 Gy within 24 Takeuchi before the first medication, and those who received within 2 weeks before the first medication Grade 1 occurred within 4 weeks before enrollment; bleeding in other parts with NCI CTC AE grade> Grade 2 occurred within 4 weeks before enrollment; hemorrhage tendency (such as active peptic ulcer) Or patients who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or their analogs. Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism. 7. Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study. 8. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders. 9. Participated in other anti-tumor drug clinical trials within four weeks. 10. Those who are allergic to the ingredients of anlotinib hydrochloride, gefitinib or metformin. 11. According to the judgment of the investigator, there is a concomitant disease that seriously endangers the safety of the patient or affects the patient to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;side effect;Cytokine detection (IL-1ß, IL-6, IL-8 and TNF-a), etc;QOL; | — |
Countries
China
Contacts
Public ContactMin Zhang
The First Affiliated Hospital of Xinxiang Medical College
Outcome results
None listed