search
Back to results

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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Placebo Capsule
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anlotinib

Placebo Capsule

Arm Description

Anlotinib QD orally and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Placebo capsule QD orally and it should be continued until disease progression or patients withdrawal of consent

Outcomes

Primary Outcome Measures

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;
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.

Secondary Outcome Measures

Full Information

First Posted
December 30, 2013
Last Updated
December 14, 2016
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborators
Tianjin Medical University Cancer Institute and Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02029209
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborators
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib
Arm Type
Experimental
Arm Description
Anlotinib QD orally and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Arm Title
Placebo Capsule
Arm Type
Placebo Comparator
Arm Description
Placebo capsule QD orally and it should be continued until disease progression or patients withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
Anlotinib QD
Intervention Type
Drug
Intervention Name(s)
Placebo Capsule
Intervention Description
Placebo capsule QD
Primary Outcome Measure Information:
Title
Number of circulating endothelial cell subsets（ total CECs 、 aCECs、apopCECs, etc.)
Description
To detect number of circulating endothelial cell subsets（ total CECs 、aCECs、apopCECs, etc.) by Flow Cytometry;
Time Frame
Different time points before and after treatment of anlotinib,an expected average of 3 weeks
Title
The strength of intratumoral blood perfusion index (BV, BF, PS and MTT) .
Description
To detect the strength of intratumoral blood perfusion index(BV, BF, PS and MTT) by CT perfusion imaging.
Time Frame
Different time points before and after treatment of anlotinib,an expected average of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Kai, doctor
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300600
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs