Clinical trial NCT02029209: To Predict Efficacy by Detecting Circulating Endothelial Cell Subsets and Blood Perfusion Parameters Changes in Vivo Tumor in the Phase II/III Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2014-01-07
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of circulating endothelial cell subsets（ total CECs 、 aCECs、apopCECs, etc.)
timeFrame: Different time points before and after treatment of anlotinib,an expected average of 3 weeks
measure: The strength of intratumoral blood perfusion index (BV, BF, PS and MTT) .
timeFrame: Different time points before and after treatment of anlotinib,an expected average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Li Kai, doctor
role: PRINCIPAL_INVESTIGATOR
References: