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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients

NCT02579564

Malignant Hydrothorax Non Small Cell Lung Cancer

UNKNOWN PHASE3

Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC)

NCT01124253

Non-small Cell Lung Cancer

COMPLETED PHASE3

Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer

NCT00576914

Non-small Cell Lung Cancer

UNKNOWN PHASE3

Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

NCT01733589

Stage III Non-small-Cell Lung Cancer

COMPLETED PHASE1/PHASE2

Second-line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)

NCT00813332

Advanced NSCLC Recurrent NSCLC

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Endostatin

Intervention Type DRUG

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

Vinorelbine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Vinorelbine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endostatin

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

Intervention Type DRUG

Vinorelbine

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

Intervention Type DRUG

Cisplatin

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Endostar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No