Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
Endostar -Continued Pumping into+GP
+ Endostar -injecting into +GP
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Lung Diseases
Treatment Study
Summary
Study start date: April 1, 2011
Actual date on which the first participant was enrolled.Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with NSCLC,and seeking for more effective injection.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Histologically or cytologically diagnosed NSCLC; primary treatment,inoperable stage IIIB/IV NSCLC; Age of 18-75years; Gender Not Required; Adequate hematologic, renal, and hepatic function ,Specific index as follows: liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l; ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy; The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI); No history of serious drug allergy; Informed consent should be obtained before treatment. Exclusion Criteria: Symptomatic brain metastases with cognitive disorder,bone metastases with complications; Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,); Serious complications and investigator consider it is unsuited enrolling; Pregnant or lactating women; Allergic to research drug; participating in other experimental trials and receive the treatment in four weeks; The position that is for observing curative effect have a radiotherapy.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location