Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC

NCT02497118 | Completed Phase 4 DMC

• 1 other identifier: TMUCIH-ENDU-S001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate and the rate of resection, At the same time, the study before and after the anti angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial growth factor(VEGF) expression level, to understanding the correlation between the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these markers. In order to find the reference basis for the prediction of the effect of curative effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer before and after treatment with CT perfusion imaging are studied.

Conditions

Non Small Cell Lung Cancer

Keywords

lung cancer Anti angiogenesis therapy survival

Outcome Measures

Primary Outcomes (1)

• Tumor Regression Rate

  Target lesion size reduction ratio

  3 months

Secondary Outcomes (3)

• Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.

  5 years

• Overall Survival

  5 years

• Clinical Benefit Rate

  3 months

Study Arms (2)

Endostatin plus NP

EXPERIMENTAL

drug:Endostatins Intravenous drip， 7.5mg/m\^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m\^2,IV, d1, d8; drug:Cisplatin，75mg/m\^2 Intravenous drip,divide into d1-3 for 2 cycles

Drug: Endostatin; Drug: Vinorelbine; Drug: Cisplatin

NP neoadjuvant chemotherapy

ACTIVE COMPARATOR

drug:vinorelbine Intravenous drip 25mg/m\^2,IV, d1, d8; drug:Cisplatin，75mg/m\^2 Intravenous drip,divide into d1-3 for 2 cycles

Drug: Vinorelbine; Drug: Cisplatin

Interventions

Endostatin DRUG

Endostatin,7.5mg/m\^2,intravenous, d1-14;

Also known as: Endostar

Endostatin plus NP

Vinorelbine DRUG

vinorelbine,25mg/m\^2,intravenous, d1, d8;

Endostatin plus NP; NP neoadjuvant chemotherapy

Cisplatin DRUG

Cisplatin，75mg/m\^2 intravenous,divide into d1-3

Endostatin plus NP; NP neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The pathology proved to be non small cell lung cancer (must be histologically).
• At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination;
• The patients were evaluated by imaging, laboratory examination and other examination;
• Without chemotherapy or anti angiogenic therapy;
• There can be measured lesions
• Informed consent.

You may not qualify if:

• Pregnant, lactating women, or patients with fertility but did not take contraceptive measures.
• Severe infection.
• Severe heart disease.Neuropsychiatric disorders, which is not easy to control.
• Severe diabetes.
• There is obvious bleeding tendency.
• The 5 years history of other tumors

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Related Publications (1)

• Zhao X, Su Y, You J, Gong L, Zhang Z, Wang M, Zhao Z, Zhang Z, Li X, Wang C. Combining antiangiogenic therapy with neoadjuvant chemotherapy increases treatment efficacy in stage IIIA (N2) non-small cell lung cancer without increasing adverse effects. Oncotarget. 2016 Sep 20;7(38):62619-62626. doi: 10.18632/oncotarget.11547.

  PMID: 27566586 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Endostatins; endostar protein; Vinorelbine; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2015
• First Posted: July 14, 2015
• Study Start: August 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 14, 2015

Record last verified: 2014-05

Locations

CN (1)