Status:
UNKNOWN
Apatinib Combined With EGFR-TKI for Advanced Slow-progressed EGFR-TKI Resistant NSCLC
Lead Sponsor:
Shenzhen People's Hospital
Conditions:
NSCLC
Apatinib
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with Apatinib and EG...
Detailed Description
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI） and progressed slowly because of resistance are und...
Eligibility Criteria
Inclusion
- Pathologically confirmed advanced (stage IV) non-squamous, non-small cell lung cancer with measurable lesions
- Electronics Coordinating Grop（ECOG）score：0-2
- Expected survival over 3months
- Hemoglobin(HB)≥90 gram(g)/liter(L)；absolute neutrophil count(ANC)≥1.5×109/L；platelet(PLT)≥80×109/L；total-bilirubin（T-BIL）\<1.5 upper limit of normal value（ULN）；alanine aminotransferase（ALT）and aspartate aminotransferase（AST）\<2.5 ULN；Cr≤1.25ULN
Exclusion
- Brain metastases, meningococcal meningitis, patients with spinal cord compression with evidence of imaging (computed tomography（CT） / magnetic resonance imaging （MRI）, et cetera（etc.）);
- Uncontrolled hypertension (systolic blood pressure（BP）≥140 millimeter mercury column（mmHg） or diastolic BP ≥90 mmHg, despite optimal drug therapy);
- Hemorrhoid dysfunction (inernational standard ratio(INR)\> 1.5 or prothrombin time (PT)\> ULN + 4 seconds or activated partial thromboplastin(APTT)\> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like;
- Patients underwent major surgery or severe traumatic injury, fracture or ulcer in 4 weeks before study;
- Urine routine urine protein ≥ +++, or confirmed 24 hours urinary protein content ≥ 1.0 g;
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03428022
Start Date
December 1 2017
End Date
December 31 2020
Last Update
April 4 2019
Active Locations (1)
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1
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020