Abreu de Carvalho Luís Filipe, Gryspeerdt Filip, Ceelen Wim, Geboes Karen, Ribeiro Suzane, Hoorens Anne, Vandenbussche Nele, Claes Kathleen B M, Lecluyse Clarisse, Anisau Aliaksandr, Van Ongeval Johan, Lybaert Willem, Triest Lars, Vervaecke Andrew, Sas Steven, Claerhout Barbara, Beyls Carolien, Sie Mark, Berrevoet Frederik
Department of HPB surgery and liver transplantation, Ghent University Hospital, Corneel Heymanslaan 10, Ghent, 9000, Belgium.
Department of Gastrointestinal surgery, Ghent University Hospital, Ghent, Belgium.
BMC Surg. 2025 May 13;25(1):204. doi: 10.1186/s12893-025-02938-1.
Neoadjuvant chemotherapy is used in borderline resectable (BR) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC) to increase resection rate and improve cancer outcome. However, there is a need for better prediction of resectability. The aim of this prospective, single arm study is to improve prediction of surgical resection by using radiomics and liquid biopsy.
In this multicentric trial, 45 patients with BR or LA PADC will undergo neoadjuvant chemotherapy with FOLFIRINOX. An intention to treat analysis will be performed. The primary endpoint is the accuracy of the prediction of surgical resection. Secondary endpoints are overall survival and disease-free survival from the date of diagnosis, R0 and R1 resection rates, histopathological response, postoperative complications, patient reported outcomes with quality of life and health economic analysis. Translational research with multi-omics and radiomics based on computed tomography and magnetic resonance imaging aims to identify factors predictive of surgical resectability and survival. The primary hypothesis is that these strategies can increase the accuracy of predicting surgical resection.
Improved prediction of resectability is necessary in BR and LA PDAC. We aim to investigate whether a combination of clinical, radiological, and multi-omics profiling in liquid biopsies can successfully predict resectability and thus optimize the therapeutic decision tree.
ClinicalTrials.gov Identifier: NCT05298722. Date of registration: March 28, 2022.
新辅助化疗用于可切除边缘（BR）和局部晚期（LA）胰腺导管腺癌（PDAC），以提高切除率并改善癌症预后。然而，需要更好地预测可切除性。这项前瞻性单臂研究的目的是通过使用放射组学和液体活检来改善手术切除的预测。
在这项多中心试验中，45例BR或LA PADC患者将接受FOLFIRINOX新辅助化疗。将进行意向性治疗分析。主要终点是手术切除预测的准确性。次要终点是从诊断日期起的总生存期和无病生存期、R0和R1切除率、组织病理学反应、术后并发症、患者报告的生活质量结果以及卫生经济分析。基于计算机断层扫描和磁共振成像的多组学和放射组学转化研究旨在识别预测手术可切除性和生存的因素。主要假设是这些策略可以提高手术切除预测的准确性。
在BR和LA PDAC中，改善可切除性的预测是必要的。我们旨在研究液体活检中的临床、放射学和多组学分析相结合是否能够成功预测可切除性，从而优化治疗决策树。
ClinicalTrials.gov标识符：NCT05298722。注册日期：2022年3月28日。
