Preventing Liver Recurrence After Partial Hepatectomy for Intrahepatic Cholangiocarcinoma Using Adjuvant Hepatic Arterial Infusion Pump Chemotherapy - PUMP IV Trial
The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are: * Does addition of chemotherapy by means of a chemo pump lead to less return of disease within the liver two years after surgery? * Does addition of chemotherapy by means of a chemo pump lead to longer survival of patients? * Does addition of chemotherapy by means of a chemo pump lead to an increase in quality of life? Participants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.
• 18 years or older
• ECOG or WHO performance status 0 or 1
• Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.
• Patient is able to undergo a laparotomy.
• Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the GDA. Accessory or aberrant hepatic arteries are no contraindication for catheter placement.
• Adequate bone marrow, liver, and renal function before inclusion (values may be max. 30 days old)
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^ 9/L
• White blood cell count (WBC) ≥ 2.5 x 10\^9/L
• Platelets ≥ 100 x 10\^9/L
• Glomerular filtration rate (GFR) ≥ 30 ml/min
• Haemoglobin (Hb) ≥ 5.5 mmol/L
• Total bilirubin ≤ 25 µmol/L
• Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations.