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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06857773 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KRAS?
Yes, KRAS mutation status known is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS mutation status known is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF V600E mutation status known is a required biomarker for enrollment.
Are patients with MMR alterations eligible?
No. MMR deficiency is an exclusion criterion.
Are patients with DPYD alterations eligible?
No. DPYD deficiency is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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