NSCLC
Conditions
Interventions
Case series:Apatinib 250mg.po.qd
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old male and female; 2. Advanced non-squamous and non-small cell lung cancer with measurable lesions (according to RECIST 1.1 standard) confirmed by pathology; 3. After EGFR-TKI (including Erlotinib, Gefitinib, Ectinib) treatment, CEA or imaging assessment of NSCLC patients with slow progression (the sum of all measured target lesion diameters and the relative increase of 0%-20% or CEA levels than before treatment); 4. There is no intervening systemic therapy between discontinuing gefitinib or erlotinib and starting new treatment; 5. ECOG PS score 0-2 points; 6. the estimated survival time is more than 12 weeks; 7. had not received chemotherapy or other targeted therapy before; 8. Patients who had previously received radiation therapy but had to be in less than 25% of the bone marrow area (Crity and Eckerman 1987) could be enrolled in the study when previous radiation therapy had to be completed for at least four weeks; 9. The main organs function normally, that is, meet the following criteria (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors to correct): (1) blood routine examination results: HB more than 90 g/L; ANC more than 1.5 x 10^9/L; PLT more than 80 x 10^9/L; (2) biochemical tests: TBIL 45 mL/min; 10. Women of childbearing age must have negative results of pregnancy tests (serum or urine) within 7 days of admission and voluntarily use appropriate contraception methods during the observation period and within 8 weeks after the last administration of Apatinib; for men, surgical sterilization should be performed, or consent should be given during the observation period and within 8 weeks after the last Administration of Apatinib. Proper methods of contraception; 11. patients voluntarily joined the study, and signed informed consent (ICF), with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. previous radiotherapy related clinical toxicity persisted; 2. radiotherapy was performed within 3 months before baseline imaging (except for limbs and brain); 3. Symptomatic brain metastases (brain metastases with stable symptoms and no symptoms of cerebral hemorrhage, which had been treated 21 days before enrollment, could be enrolled); 4. radiological evidence indicates that there are cavitary or necrotic tumors; 5. Imaging findings showed that the tumor focus was less than 5 mm away from the large vessels, or invaded the central tumor of the local large vessels, or obvious pulmonary cavity/necrotic tumor; 6. Coagulation dysfunction (INR > 1.5 x ULN, APTT > 1.5 x ULN), hemorrhagic tendency or receiving thrombolytic, anticoagulant or antiplatelet drugs, including two teaspoons of hemoptysis/hemoptysis per day in 2 months, bleeding symptoms or bleeding tendency in 3 months, bleeding tendency in 12 months. The incidence of active / venous thrombosis or other hereditary or acquired bleeding and thrombotic tendency is known; 7. Patients with hypertension who could not be reduced to normal by antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 8. long term wounds / fractures; 9. suffering from cardiovascular disease with or above grade II; 10. squamous cell carcinoma (including adenosquamous carcinoma); small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer); 11. patients with history of interstitial lung disease or with interstitial lung disease; 12. the researchers judged other situations that might affect the outcome of clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactJun Chen
Tianjin Medical University General Hospital
Outcome results
None listed