Non-small cell lung cancer
Conditions
Interventions
experimental group:EGFR-TKIs plus Anlotinib
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, regardless of gender, voluntarily participate in the experiment and sign an informed consent form; 2. Patients who have been diagnosed as NSCLC with EGFR-driven gene mutations by histopathology and genetic testing, and who have been treated with EGFR-TKIs, and have experienced slow progress through imaging and other evaluations. Slow progression is defined as: disease control for >=6 months, a slight increase in tumor burden than before, and symptom score = 90 g/L; 2) The absolute value of neutrophils (ANC) >= 1.5 x 10^9/L; 3) Platelets (PLT) >= 80 x 10^9/L; (2) The biochemical inspection shall meet the following standards: 1) Total bilirubin (TBIL) = 60ml/min; 4) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= lower limit of normal value (50%); 8. Patients of childbearing age (including female companions of female and male patients) must take effective birth control measures.
Exclusion criteria
Exclusion criteria: 1. Patients who have received other anti-angiogenesis drugs in the past; 2. Patients who are clearly T790M mutation and have not been treated with third-generation EGFR-TKIs; 3. Patients with a history of severe allergies or allergies; 4. Pregnant or lactating women; 5. Patients who have participated in other clinical trials in the past but have not terminated the trial; 6. Accompanied by pleural effusion or ascites, causing respiratory syndrome (>=CTC AE Grade 2 dyspnea); 7. Patients with brain metastases who have symptoms or whose symptom control time is less than 2 months; 8. Receive major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping; 9. Patients whose imaging shows that the tumor has invaded the important blood vessel or whose tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study as judged by the investigator; 10. Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before enrollment, patients with any bleeding or bleeding event >= CTCAE Grade 3, unhealed wounds, ulcers or fractures; Those who have had arterial/venous thrombotic events within 11.6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 12. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 13. Subjects with dysphagia or known drug absorption disorders. 14. The researcher believes that there are other situations that are not suitable for inclusion in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;adverse reactions (CTCAE 5.0); | — |
Countries
China
Contacts
Public ContactWang Zhaoxia
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed