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Search / Trial NCT06349278

Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

Launched by LAVAL UNIVERSITY · Apr 4, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Pdac Liver Metastases Pancreatic Cancer

ClinConnect Summary

This clinical trial is investigating a treatment approach for patients with pancreatic cancer that has spread to the liver. Specifically, it looks at whether giving patients a chemotherapy regimen called FOLFIRINOX before surgery can help them achieve better outcomes. The study will include patients who have a confirmed diagnosis of pancreatic ductal adenocarcinoma and have tumors that can be surgically removed, along with three or fewer liver metastases (cancer spots in the liver). Eligible participants will undergo imaging tests to ensure their cancer is manageable and will receive a total of 12 cycles of chemotherapy, with surgery planned based on how well they respond.

Participants can expect close monitoring throughout the trial. They will receive regular scans and blood tests to check their tumor markers—substances in the blood that can indicate cancer activity—before and after chemotherapy. If their tumors show improvement, they will proceed to surgery to remove the pancreatic tumor and any liver metastases. After surgery, patients will continue to be monitored for two years to track their recovery and watch for any signs of cancer returning. If they do not respond to the chemotherapy, they will receive standard treatment options. Overall, this study aims to find out if this combined treatment approach can lead to better surgical outcomes for patients with pancreatic cancer and liver metastases.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  • Resectable primary tumor based on triphasic CT-scan.
  • ≤ 3 liver metastases.
  • Liver resections can be performed by local excision or non-anatomical, partial hepatectomy. Patients with complete radiologic response after neoadjuvant FOLFIRINOX (FFX), therefore not requiring liver resection, will be included.
  • No evidence of extrahepatic metastases.
  • Patient fit for pancreatic resection (ECOG 0 or 1).
  • Stable or partial response on imaging after neoadjuvant FFX.
  • No new metastasis after neoadjuvant FFX
  • Blood tumor markers ≥ 80% decreased or within normal values after neoadjuvant FFX.
  • Exclusion Criteria:
  • Impossibility to obtain tissue diagnosis preoperatively confirming PDAC.
  • Locally advanced disease on triphasic CT-scan.
  • \> 3 liver metastases.
  • Major hepatectomy required for liver metastases (right hepatectomy, left hepatectomy, central hepatectomy, extended right or left hepatectomy).
  • Suspicion or confirmation of extrahepatic metastases.
  • Patient unfit for pancreatic resection (ECOG 2 or more).
  • Contraindication to receive FFX.

About Laval University

Laval University is a prestigious research institution located in Quebec, Canada, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. The university actively engages in clinical trials aimed at exploring new therapeutic interventions and improving patient outcomes. With a strong emphasis on ethical standards and rigorous scientific methodologies, Laval University collaborates with multidisciplinary teams of researchers, healthcare professionals, and industry partners to conduct high-quality clinical research. Its state-of-the-art facilities and dedication to fostering a culture of inquiry position Laval University as a leader in clinical research, contributing significantly to the understanding and treatment of diverse medical conditions.

Locations

Quebec City, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Alexandre Brind'Amour, MD, MSc

Principal Investigator

CHU de Québec

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported