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The purpose of this study is to find out whether treatment with Serplulimab combined with Trastuzumab and Chemotherapy will improve the survival of gastric cancer patients with stage II-III after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Treatment of Serplulimab and Trastuzuma and Chemotherapy | Experimental |
| |
| Adjuvant Chemotherapy only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab | Drug | Serplulimab: 4.5mg/Kg on day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | DFS | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS | 3-year |
| Side effects | Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 2000000 | 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 |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Trastuzuma | Drug | Trastuzuma: 8mg/Kg ( the first cycle),6mg/Kg (the rest of cycles) on day 1 |
|
| Chemotherapy | Drug | Chemotherapy: Capecitabine or S-1 and Oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² or S-1 40 mg/m2 twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease |
|
| 12 months] |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |