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This is a randomized, multicenter, controlled study to compared the Efficacy and Safety of XELOX combined with Apatinib versus XELOX as post-operative chemotherapy in locally advanced gastric signet ring carcinoma with D2 dissection.
The purpose of this study is to prove that as for disease free survival time, and safety, Apatinib with XELOX(Oxaliplatin with Capecitabine) has a better effect over that of XELOX adjunct therapy group for postoperative chemotherapy of locally advanced gastric signet ring carcinoma with D2 dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Drug:Apatinib with XELOX(Capecitabine and Oxaliplatin) |
|
| active comparator | Active Comparator | Drug:XELOX(Capecitabine and Oxaliplatin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib: 500 mg, qd, po, last 180 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival(DFS) | Disease Free Survivalof the Participants | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Overall Survival of the Participants | 8 years |
| Percentage of Participants With Adverse Events | Percentage of Participants With Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han Liang, Master | Contact | (022)23340123 | 1063 | tjlianghan@126.com |
| Mingzhi Cai, Master | Contact | 13821389052 | tsaimingzhi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Han Liang, Master | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| C519688 | XELOX |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| XELOX | Drug | Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w |
|
|
| 5 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |