Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases.

• Age ≥ 18 years

• ECOG performance status 0 or 1

• Clinical Risk Score (CRS) of 0-5

• Histologically confirmed colorectal cancer (CRC)

• Radiologically confirmed and resectable CRLM.

• Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT with excellent arterial phase. The default site for the catheter insertion is the gastroduodenal artery (GDA).

• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 15 days prior to inclusion:

o absolute neutrophil count ≥1.5 x 109/L

o platelets ≥100 x 109/L

o HB ≥ 5.5 mmol/L

o Total bilirubin ≤ 1.5 UNL

o ASAT ≤ 5 x UNL

o ALAT ≤ 5 x UNL

o alkaline phosphatase ≤ 5 x UNL

o (calculated) glomerular filtration rate >30 ml/min.

• Written informed consent must be given according to ICH/GCP, and national/local regulations.

• Presence of extrahepatic disease (including positive portal lymph nodes) at the time of liver resection or any time since CRC diagnosis. Patients with small (≤ 1 cm) extrahepatic lesions that are too small to characterize are eligible.

• Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 5 years previously without evidence of recurrence.

• Prior hepatic radiation or resection.

• CRLM requiring two-staged liver resections

• (Partial) portal vein thrombosis

• Pregnant or lactating women.

• History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.

• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

• Organ allografts requiring immunosuppressive therapy.

• Serious, non-healing wound, ulcer, or bone fracture.

• Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equivalent excluding inhaled steroids).

• Serious infections (uncontrolled or requiring treatment).

• Current or recent (within the 28 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.

• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.