跳至主要内容
临床试验/CTRI/2025/05/087919
CTRI/2025/05/087919尚未招募不适用

Predictors of tumour response to neoadjuvant chemotherapy in resected PDACs

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2025年11月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
330
试验地点
1
主要终点
To assess the factors determining tumor response after NAT in patients of PDAC treated with curative intent.

研究概览

简要总结

Pancreatic ductal adenocarcinoma PDAC is amongst the most lethal solid tumors. Curative treatment, Surgery along with chemotherapy, is feasible in only about 15% of cases since majority of the PDACs are metastatic or locally advanced at presentation. Despite the surgical advancements made in the past few years, multidisciplinary management with neo-adjuvant modalities hold the key for further improving the outcomes for PDAC. Neoadjuvant therapy holds potential in improving rate of margin negative resections R0 and allows for testing tumour biology for selecting patients who will benefit most from major pancreatic resections. In the context of PDAC though evidence is fast building up, there is still a lack of consensus on factors predicting response after neo-adjuvant therapy and in turn its effect on long-term survival. Therefore, it is essential to conduct a multicenter international study to better understand the prognostic factors for long-termsurvival in this group of patients.

In this multicenter retrospectivestudy,group of hospitals performing pancreatic surgery will participate by providing data on all the relevant preoperative, operative, and postoperative variables of patients undergoing pancreatectomy for PDAC. In the data collection we will collect information like age, medical history, neo-adjuvant therapy, surgery etc. Patients operated between 2015 and 2023 will be included. Our main goal is identify factors predicting response to neo-adjuvant therapy and its co-relation to survival.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients with histology-proven Pancreatic ductal adenocarcinoma who underwent Neoadjuvant chemotherapy with or without neoadjuvant radiotherapy and underwent curative pancreatic resections The period for recruitment -1st January 2015 to 31st December 2023.

排除标准

  • Final histology nonpancreatic ductal adenocarcinoma Patients who were deemed inoperable during surgical exploration Tumors epicenter in periampullary region (ampulla of vater, duodenum, distal bile duct) Treatment date outside of study protocol Lost to follow up.

结局指标

主要结局

To assess the factors determining tumor response after NAT in patients of PDAC treated with curative intent.

时间窗: At the end of study

次要结局

  • To study the impact of surgical outcome on OS & DFS
  • To study the impact of pCR on OS & DFS(5 years after the surgery)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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