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The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is a more effective way.
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-Carboplatin (GC)chemotherapy in patients with NSCLC,and seeking for more effective injection.
Methods:
In this randomized, open label, 90 patients are planned to be enrolled at random into 3 arms(1:1:1): Experimental: Endostar -Continued Pumping into+Gemcitabine-Carboplatin(GC),Active Comparator: Endostar -injecting into +Gemcitabine-Carboplatin(GC),Active Comparator: Gemcitabine-Carboplatin(GC),
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostar -Continued Pumping into+GC | Experimental | Endostar that is Continued Pumping into vein Combining With Gemcitabine -Carboplatin |
|
| Endostar -injecting into +GC | Active Comparator | Endostar that is injecting into vein with Gemcitabine -Carboplatin |
|
| GC | Active Comparator | Gemcitabine -Carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine,Carboplatin,Endostar | Drug | Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 48hours and the dosage is 7.5mg/m2*2 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-6cycles. |
| 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 | |
| The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood. |
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Inclusion Criteria:
Histologically or cytologically diagnosed NSCLC;
primary treatment,inoperable stage III/IV NSCLC;
Age of 18-70years; 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 | |
|---|---|---|---|---|
| Jianhua Chen, master | Contact | 0086-731-89762221 | cjh_1000@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianhua Chen, master | Hunan Province Tumor Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HuNan province tumor hospital | Recruiting | Changsha | Hunan | 410000 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 3, 2016 | |
| Reset | Jan 26, 2017 |
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|
| Gemcitabine(G) Carboplatin(C) Endostar | Drug | Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 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 2-6cycles |
|
| Gemcitabine(G) Carboplatin(C) | Drug | Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; 21 days is one cycle.Continued using 2-6cycles |
|
| two years |
| adverse reaction | two years |
| Time to progression(TTP) | two years |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 3, 2016 | Jan 26, 2017 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C522911 | endostar protein |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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