Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC)

BMC Cancer

Burkhard Deuß¹  Katrin Lutz¹  Swantje Held¹  Tobias Göser²  Dirk Waldschmidt²  Fabian Kütting²  Florian Gebauer³  Christiane Bruns³  Alexander Ioannis Damanakis³  Felix Popp³  Alexander Quaas⁴ 

[1] ClinAssess GmbH, Leverkusen, Germany;Department of Gastroenterology, University of Cologne, Cologne, Germany;Department of General, Visceral, Tumor and Transplantation Surgery, University of Cologne, Kerpener Strasse 62, 50937, Cologne, Germany;Institute of Pathology, University of Cologne, Cologne, Germany;

关键词: Chemotherapy;    Clinical trials;    Liver metastasis;    Pancreatic cancer;    Pancreatic surgery;   

DOI  :  10.1186/s12885-021-08966-3

来源: Springer

【 摘 要 】

BackgroundAccording to current guidelines, treatment of patients with hepatic oligometastasis in pancreatic cancer is not reflected and systemic chemotherapy is recommended in those patients. Retrospective data suggest beneficial outcomes in patients with hepatic oligometastasis, though prospective data from clinical trials addressing this particular patient group is not available.MethodsIn this single arm, phase-2 trial, survival data from patients receiving neoadjuvant chemotherapy followed by R0/R1 resection will be compared to historic data from patients with oligometastatic adenocarcinoma of the pancreas.The clinical trial will focus on a well-defined patient collective with metastatic load limited to the liver as target organ with a maximum of five metastases. The combination of liposomal irinotecan (nal-IRI), oxaliplatin (OX) and 5-fluouracil (5-FU)/folinic acid (FA) (nal-IRI + OX+ 5-FU/FA, NAPOX) was chosen as neoadjuvant chemotherapy; the choice was based on an ongoing clinical study in which NAPOX appeared manageable, with promising anti-tumor activity in first-line treatment of patients with metastatic pancreatic adenocarcinoma.In total 150 patients will be enrolled for this trial with an aim of 55 patients receiving a complete macroscopic synchronous tumor and metastatic resection.DiscussionThis is the first clinical study to prospectively evaluate the value of multimodality therapy concepts in oligometastatic pancreatic cancer.Trial registration numbersEudraCT 2019–002734-37; NCT04617457.

【 授权许可】

CC BY