Suspended

Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

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What is being tested

Endostar -Continued Pumping into+GP

+ Endostar -injecting into +GP

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2011
See protocol details

Summary

Principal SponsorBeijing Chest Hospital
Study ContactLiyan Xu, MDMore contacts
Last updated: September 5, 2018
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorBeijing Chest Hospital
Study ContactLiyan Xu, MDMore contacts
Last updated: September 5, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell Lung

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin

Group II

Active Comparator
Endostar that is injecting into vein with Gemcitabine -Cisplatin

Study 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

Recruiting

The Beijing Chest Hospital

Beijing, ChinaOpen The Beijing Chest Hospital in Google Maps
SuspendedOne Study Center