Lung cancer
Conditions
Interventions
Experimental group:arotinib
Sponsors
Anqing Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to the International Association for research on lung cancer and the Joint Committee of American Cancer classification 8th Edition TNM staging of lung cancer, patients with locally advanced (stage iii B / iii C), metastatic or recurrent (stage iv) lung cancer confirmed by histology or cytology and unable to receive radical concurrent chemoradiotherapy were confirmed to have at least one measurable lesion according to RECIST 1.1; 2. Aged 18 to 80 years; ECoG PS score: 0-1; The expected survival time is more than 3 months; 3. We have never received systemic anti-tumor therapy for advanced diseases, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine. Patients are allowed to have received adjuvant chemotherapy in the past, but the interval between recurrence and the last administration of chemotherapy must be at least 6 months. The end of radiotherapy must be 6 months before the first administration; Or palliative radiotherapy was completed 7 days before the first administration (except for the treatment of malignant tumor with no recurrence or metastasis for more than 5 years); 4. If the main organs function normally, they meet the following criteria: (1) Blood routine: HB >= 90g / L (no blood transfusion or EPO dependence within 14 days); ANC>=1.5x10^9 /L PLT >=100x 10^9 /L; (2) Blood biochemistry: TBIL = 60ml / min; (4) Urine protein was less than 2 + in routine urine examination, or 24-hour urine protein was less than 1G; (5) INR and Pt = lower limit of normal value (50%). 5. Patients voluntarily participated in this study, signed informed consent, good compliance.
Exclusion criteria
Exclusion criteria: 1. Lung cancer patients with active bleeding within 3 months of primary lesion (such as central squamous cell carcinoma); 2. He has received VEGF pathway targeted therapy including arotinib and bevacizumab in the past; 3. Patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.) that affect oral medication; 4. Patients with symptomatic brain metastases (except asymptomatic brain metastases or patients with stable symptoms for more than 2 weeks); 5. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Not fully recovered from toxicity and / or complications caused by any intervention (i.e. = 480ms) and congestive heart failure >= grade 2 (NYHA classification); (2) Patients with poor blood pressure control (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg); (3) Active or uncontrolled severe infection (>= CTC AE grade 2 infection); (4) Liver diseases such as cirrhosis, decompensated liver disease, active hepatitis *; *Active hepatitis (hepatitis B reference: HBsAg positive, and HBV DNA detection value exceeds the upper limit of normal value; HCV reference: HCV antibody was positive, and HCV titer detection value exceeded the upper limit of normal value. After antiviral treatment, if it is reduced to the normal range, it can be included in the study.) (5)Poor control of diabetes mellitus (FBG > 10mmol / L); (6) Active pulmonary tuberculosis, etc; (7) Renal failure requires hemodialysis or peritoneal dialysis; (8) Uncontrolled hypercalcemia (more than 1.5 mmol / L Ca2 + or more than 12 mg / dl Ca2 + or corrected serum Ca2 + more than ULN), or symptomatic hypercalcemia requiring continuous bisphosphate therapy; (9) There are long-term unhealed wounds, ulcers or fractures; (10) Patients with thyroid dysfunction. 8. No matter the severity, there are any bleeding symptoms (e.g. active peptic ulcer, peptic ulcer) Bleeding, etc.) or patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; On the premise of prothrombin time international normalized ratio (INR) 2.5 ml / day); 11. Within 28 days before randomization, the imaging findings showed that the tumor had invaded important perivascular areas, or were judged by the researchers; In the follow-up study, the patients whose tumor is likely to invade important blood vessels and cause fatal massive hemorrhage were cut off; 12. The patients who had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, hypertensive crisis or hypertensive encephalopathy; 13. Have a history of psychotropic drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall survival;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactDing Guozheng
Anqing Municipal Hospital
Outcome results
None listed