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Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.The comparative study in efficacy and safety has not been done concerning continuous and routine i.v.In addition, what patient can be benefited from Endostar have not been investigated. The biological markers, such as circulating endothelial cells,CECs, will be explored in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostar continuous intravenous infusion | Experimental | Endostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin |
|
| Endostar routine intravenous infusion | Active Comparator | Endostar routine intravenous infusion in combination with Gemcitabine and Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endostar continuous intravenous infusion | Drug | Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate based on Recist 1.1 edition | 3 months | |
| progress free survival | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 24 months | |
| Quality of life (QoL) Questionnaire | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| biological marker: CECs | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Yan, Doctor | Contact | 18622221369 | yanzhao@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
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| Endostar routine intravenous infusion | Drug | Endostar,7.5mg/m2, routine intravenous infusion 3-4 hours daily each cycle,21 days as one cycle, 4 cycles in total |
|
| Gemcitabine | Drug | Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total |
|
| Cisplatin | Drug | Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| 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 |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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