Clinical trial · Interventional
Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining
Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining After Curative Surgery of Pancreatic Cancer
NCT02486497CI-TRIAL-00029639completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hENT1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 5-FU group
- description
- Grades of hENT1 immunostaining are 0 or 1.
- interventionNames
- Biological: hENT1
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine group
- description
- Grade of hENT1 immunostaining is 2.
- interventionNames
- Biological: hENT1
Primary outcomes (1)
- measure
- Recurrence free survival
- timeFrame
- Upto 24 weeks
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with curatively resected pancreatic cancer * Age between 18 and 75 * Eastern Cooperative Oncology Group performance score 0 or 1 * Patients with compliance * Patients with informed consent Exclusion Criteria: * Patients refuse to enroll this study * Patients with concomitant chemoradiation therapy * Previous chemotherapy * Pregnant or preparing a pregnancy * Uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarction within 6 months * Enrolled another clinical trial within 30 days * Patients will be expected to be risk because of enrollment * Patients without informed consent
References
Publications (1)
- DERIVEDShin 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. PMID 33795193