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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
The purpose of this study is to evaluate the efficacy and safety of Apatinib combined with S-1 as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib plus S-1 | Experimental | Apatinib (500 mg qd p.o.) concomitantly with S-1 (40 mg/m2 qd days 1-14 q3w p.o.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Event driven, an expected average of 8 months | |
| Safety will be assessed by incidence of adverse events | An expected average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | An expected average of 8 months | |
| Disease control rate (DCR) | An expected average of 8 months | |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochun Zhang, MD, PhD | Contact | +86 0532 88905767 | zxc96701@126.com |
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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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| S-1 | Drug | S-1 (40 mg/m2 qd days 1-14 q3w p.o.) until disease progression or intolerable toxicity |
|
| Event driven, an expected average of 24 months |
| Quality of life (QoL) | Quality of life of patient will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30]. | An expected average of 24 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |