The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- survival rate
研究概览
简要总结
Pancreatic cancer is a very poor prognosis and has a high mortality rate. The clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. Gemcitabine + nab-paclitaxel (GnP) as a second-line treatment after FOLFIRINOX may be expected to be considerable. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.
详细描述
Pancreatic cancer is a very poor prognosis and has a high mortality rate. It is not clear that the improvement of clinical outcome due to anticancer drugs is not clear compared to other carcinomas. In particular, the 5-year survival rate of metastatic pancreatic cancer is still only about 2%, and the clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Meta-analysis has reported that life expectancy is significantly increased in patients receiving second-line chemotherapy after failure of primary chemotherapy. However, it is not yet clear which cancer treatment is most effective. In the NCCN guideline (ver. 2017.2), the second trial of chemotherapy for locally advanced or metastatic pancreatic cancer is the most recommended clinical trial.Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. The response rate of the treatment is 30%, and many patients require secondary chemotherapy. In a practice guideline published by the American Society of Clinical Oncology, Gemcitabine + nab-paclitaxel(GnP) is the only recommended combination for patients failing primary treatment with FOLFIRINOX. In light of the results of previous reports, the efficacy of GnP as a second-line treatment after FOLFIRINOX may be expected to be considerable, but there is a lack of studies reporting GnP therapy on the second line after FOLFIRINOX failure as a first-line treatment. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gemcitabine + nab-paclitaxel
Case with chemotherapy (Gemcitabine + nab-paclitaxel)
干预措施: Chemotherapy (Gemcitabine + nab-paclitaxel) (Drug)
结局指标
主要结局
survival rate
时间窗: 6 months
survival rate at 6 months after 2nd line chemotherapy
次要结局
- overall survival(till death or follow-up loss or end of study up to 2 years)
- Disease control rate(6 months)
- adverse event(till death or follow-up loss or end of study up to 2 years)
- Progression free survival(till death or follow-up loss or end of study up to 2 years)
研究者
Sang Hyub Lee
Professor
Seoul National University Hospital
