Non-small Cell Lung Cancer
Conditions
Brief summary
1. To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the phase II study of anlotinib in patients with advanced non-small cell lung cancer. 2. To clarify the meaning of peripheral markers and blood perfusion parameters in vivo tumor in predicting the effect of anti-angiogenic therapy.
Interventions
DRUGAnlotinib
Anlotinib QD
DRUGPlacebo Capsule
Placebo capsule QD
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Pathology diagnosed with advanced NSCLC with measurable lesions; 2. Have failed for 2 lines of chemotherapy; 3.18-70 years,ECOG PS:0-2,life expectancy of more than 3 months; 4.Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks; 5.Main organs function is normal; 6.Women of childbearing age should take contraceptive measures during the study and within 6 months after end.
Exclusion criteria
1. SCLC(including mixed with NSCLC); 2. The central cavity of Squamous cell carcinoma and hemoptysis with NSCLC; 3. Patients failed to use the anti-tumor angiogenesis therapy; 4. Patients have many influence factors toward oral medications ; 5. Brain metastases patients accompanied by symptoms or symptom control for less than two months; 6. Patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG\>10mmol/L);urine protein≥++,etc. 7. Patients failed to heal wounds or fractures for Long-term; 8. 4 weeks before enrollment, patients appeared NCI CTC AE grading \>1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade\> 2 had other parts of the bleeding; patients have a tendency to bleed (e.g active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as Warfarin, heparin or its analogues; 9. Patients occurred venous thromboembolic events within 6 months; 10. Patients who have HIV-positive or organ transplantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of circulating endothelial cell subsets（ total CECs 、 aCECs、apopCECs, etc.) | Different time points before and after treatment of anlotinib,an expected average of 3 weeks | To detect number of circulating endothelial cell subsets（ total CECs 、aCECs、apopCECs, etc.) by Flow Cytometry; |
| The strength of intratumoral blood perfusion index (BV, BF, PS and MTT) . | Different time points before and after treatment of anlotinib,an expected average of 3 weeks | To detect the strength of intratumoral blood perfusion index(BV, BF, PS and MTT) by CT perfusion imaging. |
Countries
China
Outcome results
None listed