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Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant chemotherapies have not improved the survival rate. The purpose of this study is to determine whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and intravenous administration are effective in the treatment of Borrmann type 4 gastric cancer.
Gastric cancer patients who diagnosed as Borrmann type 4 would be included in this study.They would receive 3 cycles of neoadjuvant chemotherapy with SEEOX regimen via combined intra-arterial and intravenous administration. The treatment schedule consisted of 3 courses (each, 2-week administration and 1-week withdrawal) of intra-arterial administration of oxaliplatin (150mg), etoposide (100mg) and epirubicin(30mg) by Seldinger method on day 1 and oral S-1(120mg) on days 1-14, followed by radical surgery.The efficacy and toxicity of SEEOX regimen would be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEEOX group | Experimental | A three-cycle neoadjuvant chemotherapy will be performed in all cases. In every cycle, oxaliplatin 150 mg, etoposide 100 mg and epirubicin 50 mg will be administered from the celiac artery on day 1. Oral S-1 120 mg per day will be given for days 1-14. The second cycle will be scheduled following a 1-week rest after the first cycle.After two courses of neoadjuvant chemotherapy, patients will be reevaluated and receive curative or palliative resection or exploratory laparotomy within 14 days after completing the second course of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin | Drug | oxaliplatin 150 mg will be administered from the celiac artery on day 1 of every cycle in all cases |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year survival rate | up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | up to 2 years | |
| R0 resection rate | up to 2 years | |
| Operative mortality rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi He, M.D., PhD. | Contact | +86-13851490577 | 241549864@qq.com | |
| Xulin Wang, M.D., PhD. | Contact | +86-18900672829 | 48651569@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Guoli Li, M.D. | Jinlin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research institue of general surgery, Jinling hospital | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33425441 | Derived | Xiang XS, Su Y, Li GL, Ma L, Zhou CS, Ma RF. Phase II Study of Preoperative Intra-Arterial Epirubicin, Etoposide, and Oxaliplatin Combined with Oral S-1 Chemotherapy for the Treatment of Borrmann Type 4 Gastric Cancer. J Gastric Cancer. 2020 Dec;20(4):395-407. doi: 10.5230/jgc.2020.20.e40. Epub 2020 Dec 29. |
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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 |
|---|---|
| D000077150 | Oxaliplatin |
| D005047 | Etoposide |
| D015251 | Epirubicin |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
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| etoposide | Drug | etoposide 100 mg will be administered from the celiac artery on day 1 of every cycle in all cases |
|
| epirubicin | Drug | epirubicin 30 mg will be administered from the celiac artery on day 1 of every cycle in all cases |
|
| S1 | Drug | Oral S-1 120 mg per day will be administered on days 1-14 of every cycle in all cases |
|
| up to 2 years |
| in-hospital mortality rate | up to 2 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |