Overview

Chemotherapy and Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas

Status:
Recruiting
Trial end date:
2025-09-30
Target enrollment:
Participant gender:
Summary
This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial. Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant combination chemotherapy (liposomal irinotecan, oxaliplatin, 5-fluouracil, folinic acid (NAPOX)) in cycles of 14 days. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.
Phase:
Phase 2
Details
Lead Sponsor:
University of Cologne
Collaborator:
Servier
Treatments:
Fluorouracil
Folic Acid
Irinotecan
Leucovorin
Levoleucovorin
Oxaliplatin