Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02497118
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endostatin plus NP Endostatin 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 Endostatin plus NP Vinorelbine 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 Endostatin plus NP Cisplatin 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 NP neoadjuvant chemotherapy Vinorelbine drug:vinorelbine Intravenous drip 25mg/m\^2,IV, d1, d8; drug:Cisplatin，75mg/m\^2 Intravenous drip,divide into d1-3 for 2 cycles NP neoadjuvant chemotherapy Cisplatin 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 Measures
Name Time Method Tumor Regression Rate 3 months Target lesion size reduction ratio
- Secondary Outcome Measures
Name Time Method Disease free survival is defined as the time from randomization to disease recurrence or death which comes first. 5 years Overall Survival 5 years the time from randomization to death.
Clinical Benefit Rate 3 months
Trial Locations
- Locations (1)
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China