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Antiangiogenesis therapy plays an important role in cancer treatment. Apatinib showed good safety and efficacy as third-line therapy for advanced gastric cancer.We conducted this trial to investigate the safety and efficacy of apatinib combined with S1 after failure of first-line chemotherapy in advanced gastric cancer or gastroesophageal junction carcinoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib plus S1 | Experimental | patients with advanced gastric cancer enrolled after failure of first-line systemic chemotherapy will be given Apatinib plus S1 till progressive disease,death or non-tolerable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | defined as the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 6 weeks of therapy | Approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | defined as the time from randomize to death | Approximately 2 years |
| Safety (incidence of adverse events) | incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Deng, M.D. | Contact | +8613426136152 | dengweiwei@126.com | |
| Zhigang Bai, M.D. | Contact | +8613126617140 | bai_zhg@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Deng, M.D. | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | 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 |
| C079198 | S 1 (combination) |
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| Approximately 1 year |
| Quality of life(QoL) | as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30) | Approximately 2 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |