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This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced Gastric Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance Treatment Group A | Experimental | Maintenance Treatment with Capecitabine plus Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer |
|
| Observation Group | No Intervention | Observation after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer | |
| Maintenance Treatment Group B | Experimental | Maintenance Treatment with Apatinib after First-line XELOX chemotherapy for Patients with Advanced Gastric Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib+Capecitabine | Drug | Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | From date of randomization until the date of first documented death from any cause, assessed up to 36 months | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianglin Yuan, PhD,MD | Contact | 8627-83663406 | xlyuan1020@163.com | |
| Ping Peng, PhD,MD | Contact | 8627-83663407 | pengpingtj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianglin Yuan, PhD,MD | Tongji Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
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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 |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Apatinib | Drug | Apatinib 250mg po Qd |
|
| 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 |