NCT06349278: PDAC-LIV

Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

Recruiting now NA Last updated 16 April 2024

What this trial tests

NA trial testing Pancreatic resection and non-anatomic liver resections. in Pancreas Adenocarcinoma in 15 participants. Currently enrolling.

Timeline

16 January 2024

Primary endpoint
16 January 2026

16 January 2029

Quick facts

Lead sponsor	Laval University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	16 January 2024
Primary completion	16 January 2026
Estimated completion	16 January 2029
Sites	1 location across Canada

Drugs / interventions tested

• Pancreatic resection and non-anatomic liver resections.

Conditions studied

• Pancreas Adenocarcinoma — all drugs for Pancreas Adenocarcinoma →
• Pancreas Metastases — all drugs for Pancreas Metastases →
• Pancreas Cancer — all drugs for Pancreas Cancer →

Sponsor

Laval University

Who can join

18 and older, any sex, with Pancreas Adenocarcinoma or Pancreas Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, pilot study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough, standard of care assessment for both pancreatic primary and liver metastases resectability with blood tumor markers (CEA, CA 19-9 and CA-125), triphasic CT-scan and liver magnetic resonance imaging (MRI), patients with resectable pancreatic ductal adenocarcinoma primary and three or less resectable liver metastases will be prospectively included in the study. PET-scan may be added to the investigation depending on CT-scan or MRI results to prove metastatic disease or rule out extrahepatic metastases. Patients will receive a total of 12 cycles of perioperative FOLFIRINOX (FFX), with first reassessment with triphasic CT-scan to monitor tumor response after the first six cycles. Every patient will receive at least 6 cycles of FFX before surgery. The remaining six cycles will be received either preoperatively or postoperatively, depending on patient tolerance and tumor response at reassessment. Patients with liver metastases only visible on MRI will also have liver MRI at reassessment, which is also standard of care. Patients with evidence of tumor response on both imaging using RECIST V.1.1 criteria (stable disease or partial response), and blood tumor markers (≥ 80% decrease and/or normalization of all tumor markers) will then undergo pancreatic resection, either distal pancreatectomy or pancreatoduodenectomy depending on tumor side, with liver metastases excision. Each case will be followed with blood tumor markers and CT-scan every three months for two years, and every four months afterwards or until recurrence, which is standard of care for patients with metastatic PDAC. For patients without evidence of tumor response on imaging, or \< 80% decrease of all tumor markers, the standard palliative systemic treatment will be continued.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.