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| Name | Class |
|---|---|
| Duke University | OTHER |
| Geneplus-Beijing Co. Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness dendritic cell activated Cytokine induced killer treatment (DC-CIK) plus S-1 based chemotherapy for advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC-CIK plus S-1 based chemotherapy | Experimental | Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone. Meanwhile those patients will receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent. |
|
| S-1 based chemotherapy | Active Comparator | Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone.Cycles were repeated every 21 days. Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-CIK | Biological | Patients will be receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 4 years | |
| Response rate | Every 6 weeks | |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University Cancer Center | Beijing | Beijing Municipality | 100038 | 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 |
|---|---|
| C079198 | S 1 (combination) |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| S-1 | Drug | The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25 to <1.5 m2, 50 mg; and ≥1.5 m2, 60 mg, given twice daily after meals for 14 days followed by 7 days rest. |
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| Cisplatin | Drug | Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days. |
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| Every 3 weeks |
| Quality of life | Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment. | 6 weeks |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |