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

NCT02029209 | Unknown Phase 2 DMC

• 1 other identifier: ALTN-03-II 1.2-2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To clarify the meaning of peripheral markers and blood perfusion parameters in vivo tumor in predicting the effect of anti-angiogenic therapy.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Anlotinib

EXPERIMENTAL

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

Drug: Anlotinib

Placebo Capsule

PLACEBO COMPARATOR

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

Drug: Placebo Capsule

Interventions

Anlotinib DRUG

Anlotinib QD

Anlotinib

Placebo Capsule DRUG

Placebo capsule QD

Placebo Capsule

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

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

Tianjin, Tianjin Municipality, 300600, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Kai, doctor

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 7, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

CN (1)