Hepatic Arterial Infusion PUMP Chemotherapy Combined With Systemic Therapy Versus Systemic Therapy Alone as Induction Therapy for Initially Unresectable Colorectal Liver Metastases: a Randomised Controlled Trial (PUMP-IT RCT)

NCT06857773 Phase 3 RECRUITING

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

Details

Lead sponsor	The Netherlands Cancer Institute
Phase	Phase 3
Status	RECRUITING
Enrolment	306
Start date	2024-11-21
Completion	2035-01

Conditions

• Colorectal Neoplasms
• Floxuridine
• Liver Metastases
• Vascular Access Device

Interventions

• Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy
• Hepatic arterial infusion pump (HAIP)
• Systemic therapy (standard of care)

Primary outcomes

• Overall survival — Up to five years after randomization
  Defined as the time between randomization and the event of death.

Countries

Netherlands