Clinical trial NCT02497118: Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC
Official title: Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage ⅢA Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Small Cell Lung Cancer
Keywords: lung cancer Anti angiogenesis therapy survival
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tumor Regression Rate
timeFrame: 3 months
Secondary outcomes:
measure: Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
measure: Clinical Benefit Rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References:
citation: 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.