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

Non-small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02029209
• Other study ID #: ALTN-03-II 1.2-2
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: December 30, 2013
• Last updated: December 14, 2016
• Start date: December 2013
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Anlotinib
Anlotinib QD
• Placebo Capsule
Placebo capsule QD

Locations

Country	Name	City	State
China	20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd	Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of circulating endothelial cell subsets( total CECs ? aCECs?apopCECs, etc.)	To detect number of circulating endothelial cell subsets( total CECs ?aCECs?apopCECs, etc.) by Flow Cytometry;	Different time points before and after treatment of anlotinib,an expected average of 3 weeks	No
Primary	The strength of intratumoral blood perfusion index (BV, BF, PS and MTT) .	To detect the strength of intratumoral blood perfusion index(BV, BF, PS and MTT) by CT perfusion imaging.	Different time points before and after treatment of anlotinib,an expected average of 3 weeks	No