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

Study Overview
=================
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.

Official Title
-----------------
Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage ⅢA Non Small Cell Lung Cancer

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Endostatin
* Drug: Vinorelbine
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endostatin plus NP<br>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<br>* Endostatin,7.5mg/m^2,intravenous, d1-14;<br>* Other names: Endostar;Drug: Vinorelbine<br>* vinorelbine,25mg/m^2,intravenous, d1, d8;<br>Drug: Cisplatin<br>* Cisplatin，75mg/m^2 intravenous,divide into d1-3<br>|
| Active Comparator: NP neoadjuvant chemotherapy<br>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<br>* vinorelbine,25mg/m^2,intravenous, d1, d8;<br>Drug: Cisplatin<br>* Cisplatin，75mg/m^2 intravenous,divide into d1-3<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Regression Rate | Target lesion size reduction ratio | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival is defined as the time from randomization to disease recurrence or death which comes first. |  | 5 years | 
| Overall Survival | the time from randomization to death. | 5 years | 
| Clinical Benefit Rate |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer Anti angiogenesis therapy survival