跳至主要内容
临床试验/NCT03401827
NCT03401827Unknown4 期

The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月1日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Gemcitabine + nab-paclitaxel

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sang Hyub Lee

Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验