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SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorouracil Implants and Xelox regimes | Active Comparator | Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation. Xelox regimes: Capecitabine,1000 mg/m2,PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2,IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished. |
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| Xelox regimes | Active Comparator | Xelox regimes: Capecitabine,1000 mg/m2,PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2,IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorouracil Implants | Drug | Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation. |
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| Measure | Description | Time Frame |
|---|---|---|
| DFS (Disease Free Survival) | During 3 years of monitoring period, any cancer relapse will be recorded | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event | During 3 years of monitoring period, any AEs will be recorded | 3 years |
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Inclusion Criteria:
9. the authorized ICF must be signed
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Xu, Doctor | Contact | 13204032770 | xyab@sina.com | |
| Bo Li, Doctor | Contact | 13940018765 | ydyyllwyh2010@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heilongjiang Cancer Hospital | Recruiting | Harebin | Heilongjiang | 150000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34307140 | Derived | Xu Y, Zhang R, Li C, Sun Z, Deng J, Wang X, Ding X, Wang B, Xue Q, Ke B, Zhan H, Liu N, Liu Y, Wang X, Liang H, Xue Y, Xu H. Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study. Front Oncol. 2021 Jul 8;11:670651. doi: 10.3389/fonc.2021.670651. eCollection 2021. |
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| Xelox regimes | Drug | Xelox regimes: Capecitabine,1000 mg/m2,PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2,IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished. |
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