Surgery for pancreatic cancer with liver metastases after chemotherapy
Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX: a Prospective, Pilot Study
This study is testing whether surgery after chemotherapy can help people with pancreatic cancer that has spread to the liver live longer and have better outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06349278 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates patients with resectable pancreatic ductal adenocarcinoma and up to three liver metastases who will undergo surgery following neoadjuvant chemotherapy with FOLFIRINOX. Patients will receive a total of 12 cycles of chemotherapy, with imaging assessments to monitor tumor response before surgery. The study aims to determine the feasibility and outcomes of surgical resection in this patient population. The approach includes thorough preoperative evaluations using various imaging techniques to ensure optimal patient selection for surgery.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with pancreatic ductal adenocarcinoma who have a resectable primary tumor and three or fewer liver metastases.
Not a fit: Patients with locally advanced disease, more than three liver metastases, or those requiring major liver resections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and survival rates for patients with pancreatic cancer and liver metastases.
How similar studies have performed: While similar approaches have been explored, this specific combination of neoadjuvant chemotherapy followed by resection in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Québec, Quebec
- CHU de Québec — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Alexandre Brind'Amour, MD, MSc — CHU de Québec
- Study coordinator: Alexandre Brind'Amour, MD, MSc
- Email: alexandre.brindamour.1@ulaval.ca
- Phone: 418-691-5370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.