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The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostar -Continued Pumping into+GP | Experimental | Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin |
|
| Endostar -injecting into +GP | Active Comparator | Endostar that is injecting into vein with Gemcitabine -Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar -Continued Pumping into+GP | Drug | Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | two years | |
| Clinical benefit rate (CBR) | two years | |
| Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liyan Xu, MD | Contact | xuliyan2009@yahoo.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Beijing Chest Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| Endostar -injecting into +GP | Drug | Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-4cycles |
|
| two years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |