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

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 tu

Trial Details

NCT ID
NCT06857773
Phase
PHASE3
Sponsor
The Netherlands Cancer Institute
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Intra arterial infusion Floxuridine (FUDR) combined with systemic therapy
  • Hepatic arterial infusion pump (HAIP)
  • Systemic therapy (standard of care)
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969

Key Eligibility Criteria

  • Age ≥ 18 years.
  • Histologically confirmed colorectal adenocarcinoma.
  • Unresectable synchronous CRLM according to a National Liver Panel (CT-scan obtained ≤ 4 weeks prior to registration).
  • No extrahepatic metastases. Patients with small (≤ 10 mm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.

For full eligibility, visit ClinicalTrials.gov.

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