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

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

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Endostatin; Drug: Vinorelbine; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 5, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): July 14, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: lung cancer Anti angiogenesis therapy survival
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Cisplatin; Vinorelbine; Endostatins
• Other Study ID Numbers: TMUCIH-ENDU-S001