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NCT Number: NCT02497118

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

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endostatin

Drug

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

Other names: Endostar

Vinorelbine

Drug

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

Cisplatin

Drug

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

Primary outcomes

  1. Tumor Regression Rate

    Time frame: 3 months

    Target lesion size reduction ratio

Secondary outcomes

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

    Time frame: 5 years

  2. Overall Survival

    Time frame: 5 years

    the time from randomization to death.

  3. Clinical Benefit Rate

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 14, 2015
Registry last updated
Jul 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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