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| Name | Class |
|---|---|
| Xiansheng Pharmaceutical Company | UNKNOWN |
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The purpose of this study is to investigate whether endostar (recombinant human endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective and safe.
Endostar, a recombinant human endostatin, has shown its antitumor ability in combination in NSCLC and breast cancer. But to gastric cancer, few clinical data has been reported. However, bevacizumab, an angiogenesis inhibitor was shown effective in combination with chemotherapy in advanced gastric cancer in some phase II study. So in this study, we want to explore whether endostar is also effective and safe in advanced gastric cancer. Response predictive factor is expected to be identified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endostar+chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endostar, cisplatin, capecitabine | Drug | Product 1: endostar Dosing schedule: 15mg daily dose, d1-14 Mode of administration: intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate | 1 year | |
| Disease control rate | 1 year | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| lin shen, MD | Peking University, School of oncology, Department of GI oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of GI Oncology, Peking University, School of Oncology | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| C522911 | endostar protein |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| capecitabine | Drug | Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally |
|
| cisplatin | Drug | Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously |
|
| 5 year |
| adverse evens | 5 year |
| The alteration of relative regional blood volume of the tumor | 3weeks |
| D003841 |
| Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |