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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497118
• Other study ID #: TMUCIH-ENDU-S001
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2015
• Last updated: July 13, 2015
• Start date: August 2010
• Est. completion date: June 2015

Study information

• Verified date: May 2014
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The pathology proved to be non small cell lung cancer (must be histologically).

• At present, the patients with ?A 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Endostatin
Endostatin,7.5mg/m^2,intravenous, d1-14;
• Vinorelbine
vinorelbine,25mg/m^2,intravenous, d1, d8;
• Cisplatin
Cisplatin,75mg/m^2 intravenous,divide into d1-3

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Regression Rate	Target lesion size reduction ratio	3 months	No
Secondary	Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.		5 years	No
Secondary	Overall Survival	the time from randomization to death.	5 years	No
Secondary	Clinical Benefit Rate		3 months	No