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临床试验/NCT04110769
NCT04110769Unknown不适用

Development of Biomarker for the Evaluation of Response After Neoadjuvant Therapy in Patients With Pancreatic Cancer

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年7月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
The rate of genetic mutation

研究概览

简要总结

The purpose of this study is to identify and apply biomarkers that can provide better information than previous imaging and blood tests when evaluating the response after neoadjuvant chemotherapy in pancreatic cancer patients who require neoadjuvant therapy before surgery.

详细描述

BACKGROUND

  • Pancreatic cancer is a rare cancer of the digestive system, but it is known to have a poor prognosis with a very poor survival rate. Five-year survival rate of all patients with pancreatic cancer is less than 6%, and only 10-20% of patients are eligible for surgery at the time of diagnosis.
  • Postoperative complications of pancreatic cancer are reported in 30-50% of cases, and only 50% of patients undergoing postoperative chemotherapy at the appropriate time after surgery are reported. As a result of these concerns, the study of neoadjuvant chemotherapy (NACT) was begun. Recently, several clinical studies of chemotherapy have been performed. Cancer (BRPC), locally advanced pancreatic cancer (LAPC) patients who have had difficult surgical resection, are turning to treatment by combining surgical treatment after NACT.
  • Although standard treatments for advanced chemotherapy have yet to be established through many clinical studies, the most commonly used regimens are FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), gemcitabine and nab-paclitaxel. The response rate after prior chemotherapy is known as 30-50%, and the response of patients undergoing surgery after prior chemotherapy was compared with the serum markers before and after chemotherapy through CA19-9, PET-CT, and CT. The response could be estimated by the reduction, the size change in the imaging test, or the decrease in SUVmax. However, there are only a few studies on genetic and molecular studies of which patients will respond. Under these circumstances, this study on the discovery of biomarkers for the response of advanced chemotherapy in patients with pancreatic cancer may provide guidelines for the application of advanced chemotherapy and the selection of appropriate drugs, as well as clues for future research.

Primary endpoint:

-Discovery of genetic mutation in response to NACT

METHODOLOGY Recruitment and sample collection of patients undergoing NACT Identifying pancreatic cancer specific candidate genes in response to NACT

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
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

  • The patients who are going to administer neoadjuvant chemotherapy for borderline resectable or locally advanced pancreatic cancer
  • Performance: 0-2
  • No distant metastasis
  • Patients who consented to and signed the consent

排除标准

  • Distant metastasis
  • Patients included in other clinical studies that may affect this study
  • Patients who cannot follow the directions of the researcher
  • Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)
  • Pelvic tumor, benign tumor, malignant tumor in other organs
  • Patients who received prior chemotherapy

结局指标

主要结局

The rate of genetic mutation

时间窗: before neoadjuvant chemotherapy

Discovery of genetic mutation in response to neoadjuvant chemotherapy

次要结局

  • oncologic outcome(3 - 5 years after surgery)

研究者

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

Song Cheol Kim

Professor

Asan Medical Center

研究点 (2)

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