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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

NCT ID: NCT02029209

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anlotinib

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

Group Type EXPERIMENTAL

Anlotinib

Intervention Type DRUG

Anlotinib QD

Placebo Capsule

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

Group Type PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type DRUG

Placebo capsule QD

Interventions

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Anlotinib

Anlotinib QD

Intervention Type DRUG

Placebo Capsule

Placebo capsule QD

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Kai, doctor

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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ALTN-03-II 1.2-2

Identifier Type: -

Identifier Source: org_study_id