Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining After Curative Surgery of Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recurrence free survival
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
5-FU group
Grades of hENT1 immunostaining are 0 or 1.
干预措施: hENT1 (Biological)
Gemcitabine group
Grade of hENT1 immunostaining is 2.
干预措施: hENT1 (Biological)
结局指标
主要结局
Recurrence free survival
时间窗: Upto 24 weeks
次要结局
- Overall survival(Upto 24 weeks)
- Toxicity(Upto 24 weeks)