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| Name | Class |
|---|---|
| IlDong Pharmaceutical Co Ltd | INDUSTRY |
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Human equilibrative nucleoside transporter 1 (hENT1) is a membrane transporter which is a predicting marker for gemcitabine chemotherapy. However, there is a limited evidence of it as an indicator for adjuvant gemcitabine chemotherapy. In this study, investigators try to investigate the role of hENT1 as a indicator of selection of adjuvant chemotherapy regimen between gemcitabine and 5-fluorouracil (5-FU).
After surgical resection of pancreatic cancer, the tissue is immunostained by hENT1 antibody. The grades of immunostaining are categorized as 0 (0%), 1 (<50%), and 2 (>=50%). According to the grade, patients with grade 0 or 1 will be treated with 5-FU and those with grade 2 will be treated with gemcitabine. After the study, investigators will calculate the overall survival and recurrence free survival of the patients and investigate the role of hENT1 as a predictive biomarker for adjuvant gemcitabine chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-FU group | Active Comparator | Grades of hENT1 immunostaining are 0 or 1. |
|
| Gemcitabine group | Active Comparator | Grade of hENT1 immunostaining is 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hENT1 | Biological | hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival | Upto 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Upto 24 weeks | |
| Toxicity | Hematologic and hepatic toxicity according to blood test results & non-hematologic toxicity (fatigue, vomiting, diarrhea, sensory neuropathy) according to CTCAE 4.0 scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33795193 | Derived | Shin DW, Lee JC, Kim J, Yoon YS, Han HS, Kim H, Hwang JH. Tailored adjuvant gemcitabine versus 5-fluorouracil/folinic acid based on hENT1 immunohistochemical staining in resected pancreatic ductal adenocarcinoma: A biomarker stratified prospective trial. Pancreatology. 2021 Jun;21(4):796-804. doi: 10.1016/j.pan.2021.02.022. Epub 2021 Mar 4. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Upto 24 weeks |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |