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

Exclusion Criteria

• •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.
• •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.
• •Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency
• •Prior hepatic radiation, ablation, or resection for iCCA.
• •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.
• •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 infections (uncontrolled or requiring treatment).
• •Participation in another interventional study for iCCA with survival as outcome.
• •Participation in another prospective study with an interventional medical product.
• •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