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

NCT06857773 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2025-03-04

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy

Floxuridine is administered via the hepatic arterial infusion pump directly to the hepatic artery with a continous flowrate for a period of 2 weeks. Intra arterial infusion of FUDR is combined with systemic therapy (FOLFOX/FOLFIRI) intravenously. Administration of FUDR via the chemopump is every 4 weeks and systemic therapy is administered every 2 weeks.

DEVICE

Hepatic arterial infusion pump (HAIP)

The HAIP (pump) is implanted during surgery combined with resection of the primary tumor before start of induction treatment with Floxuridine and concomitant systemic therapy

DRUG

Systemic therapy (standard of care)

Patient included in the control arm will receive systemic therapy according to standard clinical practice. Induction therapy regimens include: CAPOX (3 weekly) or FOLFOX/FOLFIRI/FOLFOXIRI (2weekly) with optional addition of Bevacizumab (2 weekly)

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2030-01-31
Completion
2035-01-31
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06857773 on ClinicalTrials.gov