Treatment for Bile Duct Cancer in the Liver

Inclusion criteria

• Age>18 years
• Histological or cytological diagnosis of cholangiocarcinoma
• Disease not amenable to surgery
• Predominant disease load in the liver (in case of extra-hepatic involvement, only patients with lymph nodes metastases are allowed)
• Naïve to locoregional or systemic treatment (but patients who develop recurrent disease after surgery are suitable)
• ECOG PS 0-1
• At least one measurable disease lesion according to RECIST v 1.1
• Life expectancy of 12 weeks or longer
• Adequate hematological, renal and hepatic function
• Platelet ≥100 x 109
• ANC ≥ 1.5 x 109
• Bilirubin ≤ 30µmol/L
• Albumin ≥ 30g/L
• ALT ≤ 3 ULN
• INR ≤ 1.5
• Serum creatinine ≤ 1.5 x ULN

Exclusion criteria

• Prior malignancy except cervical carcinoma-in-situ or treated basal cell carcinoma. Any cancers treated curatively > 5 years prior to study entry are permitted.
• Patients with extra-hepatic disease other than regional lymph node metastases.
• Evidence of ascites or cirrhosis, as determined by clinical or radiologic assessment
• Biliary obstruction with no possibility of drainage
• Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
• Prior treatment of chemotherapy for the cholangiocarcinoma
• Prior radiation therapy to the upper abdomen
• Complete thrombosis of the main portal vein
• Tumor volume > 50% of the normal liver volume
• Allergy to non-ionic contrast agents