Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy

Summary

The goal of this randomized clinical trial is to investigate induction treatment with Hepatic Arterial Infusion Pump therapy combined with systemic therapy (HAIP-SYST) in chemotherapy-naive patients with unresectable colorectal liver metastases without extrahepatic disease. The main question it aims to answer is if combined HAIP-SYST improves survival compared to induction treatment with systemic therapy alone. Patients in the control arm will receive systemic therapy according to standard of care. Study procedures experimental arm * Surgery for pump placement and resection of the primary tumor * Pre- and postoperative imaging (CT-anghiography, 99mTc-MAA scintigraphy) * Induction treatment with hepatic arterial infusion pump therapy with Floxuridine combined with systemic therapy Study procedures both arms * Evaluation of resectability status by a National Liver Panel with surgeons and radiologists * Questionnaires for Quality of Life

Timeline

Start

2024-11-21

Primary completion

2030-01

Completion

2035-01

Publications

• Ter Kuile EM, Kok N, Westerink B, Swijnenburg RJ, Daletzakis A, Jacobs B, Retel VP, van Golen LW, Snaebjornsson P, Klompenhouwer EG, Koerkamp BG, Buffart TE, Punt C, Verhoef C, Bolhuis K, Kuhlmann K; Dutch PUMP-IT study group. Hepatic arterial infusion pump chemotherapy combined with systemic therapy versus systemic therapy alone as induction treatment for initially unresectable colorectal liver metastases: a study protocol of the randomised controlled trial - PUMP-IT RCT. BMC Cancer. 2026 May 16;26(1):827. doi: 10.1186/s12885-026-16130-y.

Drugs

Indications