Development of Biomarker for the Evaluation of Response After Neoadjuvant Therapy in Patients With Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Responders
The investigator will administer neoadjuvant chemotherapy After neoadjuvant chemotherapy, multidisciplinary team will decide to surgery or continuing chemotherapy based on following imaging studies and tumor markers.
The patients who undergo surgery after neoadjuvant chemotherapy will be included responders.
干预措施: next generation sequencing (Diagnostic Test)
Non-responders
The patients who show cancer progression even after neoadjuvant chemotherapy will be classify with non-responder. And the investigator will change palliative chemotherapy.
干预措施: next generation sequencing (Diagnostic Test)
Non-responders
The patients who show cancer progression even after neoadjuvant chemotherapy will be classify with non-responder. And the investigator will change palliative chemotherapy.
干预措施: following next generation sequencing (Diagnostic Test)
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
Song Cheol Kim
Professor
Asan Medical Center