OncoMatch/Clinical Trials/NCT06857773
Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy
Is NCT06857773 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy and Hepatic arterial infusion pump (HAIP) for colorectal neoplasms.
Treatment: Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy · Hepatic arterial infusion pump (HAIP) · Systemic therapy (standard of care) — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS mutation status known
Known mutation status of RAS
Required: NRAS mutation status known
Known mutation status of RAS
Required: BRAF V600E mutation status known
Known mutation status of BRAFV600E
Excluded: MMR deficiency
MMR deficiency
Excluded: DPYD deficiency
DPD-deficiency
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: hepatic radiation
Cannot have received: hepatic resection
Cannot have received: hepatic ablation
Lab requirements
Blood counts
Hb ≥ 5.5 mmol/L; ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L
Kidney function
Serum creatinine ≤ 1.5 x ULN or MDRD (eGFR) ≥ 45 ml/min
Liver function
total bilirubin ≤ 1.5 x ULN; ASAT/AST ≤ 5 x ULN; ALAT/ALT ≤ 5 x ULN; alkaline phosphatase ≤ 5 x ULN
Laboratory requirements: i.e. adequate bone marrow, liver and renal function (obtained within 15 days prior to registration).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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