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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT02497118
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 31, 2010
Status verified
May 2014
Primary completion
Apr 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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

Primary Outcome Measure

Tumor Regression Rate [ Time Frame: 3 months ]

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