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

Tianjin Medical University

Status and phase: Completed; Phase 4

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Endostatin; Drug: Cisplatin; Drug: Vinorelbine

Study type: Interventional

Funder types: Other

Identifiers

NCT02497118

TMUCIH-ENDU-S001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Endostatin plus NP

Experimental group

Description:

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

Treatment:

Drug: Endostatin

Drug: Cisplatin

Drug: Vinorelbine

NP neoadjuvant chemotherapy

Active Comparator group

Description:

drug:vinorelbine Intravenous drip 25mg/m\^2,IV, d1, d8; drug:Cisplatin，75mg/m\^2 Intravenous drip,divide into d1-3 for 2 cycles

Treatment:

Drug: Cisplatin

Drug: Vinorelbine