Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery

Ki vehet részt

• 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

Ki nem vehet részt

• Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence or with a life expectancy longer than 5 years
• Prior hepatic radiation, ablation, or resection for iCCA
• 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
• Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (≤ 1 cm) extrahepatic lesions that are too small to characterize or biopsy are eligible
• Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed
• (Partial) portal vein thrombosis in future liver remnant
• History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy
• Serious infections (uncontrolled or requiring treatment)
• 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
• Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency
• Pregnant or lactating women
• Participation in another interventional study for iCCA with survival as outcome
• Participation in another prospective study with an interventional medical product