Unknown statusInterventionalPhase 3Updated Aug 29, 2019
To Predict Efficacy by Detecting Circulating Endothelial Cell Subsets and Blood Perfusion Parameters Changes in Vivo Tumor in the Phase II/III... | NCT02029209 | Trialant
Unknown statusInterventionalPhase 2Phase 3Updated Dec 16, 2016
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
ClinicalTrials.gov ID
NCT02029209
Lead Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.INDUSTRY
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 2Phase 3
Enrollment
110Estimated
Last Update Posted
Dec 16, 2016Estimated
Start Date
Dec 2013
Primary Completion Date
Mar 2017Estimated
Completion Date
Mar 2017Estimated
Brief Summary
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.
To clarify the meaning of peripheral markers and blood perfusion parameters in vivo tumor in predicting the effect of anti-angiogenic therapy.
Non-small Cell Lung Cancer
Anlotinib
Placebo Capsule
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathology diagnosed with advanced NSCLC with measurable lesions;
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:
SCLC(including mixed with NSCLC);
The central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
Patients failed to use the anti-tumor angiogenesis therapy;
Patients have many influence factors toward oral medications ;
Brain metastases patients accompanied by symptoms or symptom control for less than two months;
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.
Patients failed to heal wounds or fractures for Long-term;
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;
Patients occurred venous thromboembolic events within 6 months;
Patients who have HIV-positive or organ transplantation.
Primary Purpose
Basic Science
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
No central contacts
There are no central contacts for this study.
20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
Tianjin, Tianjin Municipality 300600, China
Lead Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.INDUSTRY
Collaborators
Tianjin Medical University Cancer Institute and HospitalOTHER