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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Anlotinib; Drug: Placebo Capsule

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300600
      • 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib; Anlotinib QD orally and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent	Drug: Anlotinib; Anlotinib QD
Placebo Comparator: Placebo Capsule; Placebo capsule QD orally and it should be continued until disease progression or patients withdrawal of consent	Drug: Placebo Capsule; Placebo capsule QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Collaborators: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: Li Kai, doctor, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ALTN-03-II 1.2-2