RecruitingPhase 3NCT06857773

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

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

Sponsor

The Netherlands Cancer Institute

Enrollment

306 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Liver Metastases Colorectal Neoplasms Floxuridine Vascular Access Device

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of hepatic arterial infusion pump (HAIP) chemotherapy — which delivers high-dose chemo directly into the liver's blood supply — along with standard systemic chemotherapy, for patients whose colorectal cancer has spread to the liver and cannot yet be surgically removed. **You may be eligible if...** - You are 18 or older with confirmed colorectal adenocarcinoma - Your liver metastases are currently unresectable (cannot be surgically removed), confirmed by a specialist panel - You have no spread beyond the liver (or only very small, suspicious lesions) - You have not received any prior chemotherapy for colorectal cancer - The surgical placement of a pump catheter in your liver artery is technically feasible based on imaging **You may NOT be eligible if...** - You have had prior liver radiation, surgery, or ablation - You have another serious cancer or condition that would interfere with treatment or prognosis - You have had another cancer (unless treated with curative intent and in remission for 3+ years) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntra 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.

DEVICEHepatic 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

DRUGSystemic 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)