Clinical Research Directory

Inclusion Criteria: * Histological diagnosis of iCCA (biopsy-proven tumor) * Either first diagnosis or post-resection recurrence (occurring ≥ 6 months after resection) * Unresectability assessment due to tumor location (leading to insufficient live remnant with/out implementation of hypertrophic parenchymal techniques) or underlying liver disease. Non-resectability assessed by an expert surgical team with experience on both resection and transplantation (centralized at INT Milan). * Age between 18 and 70 years * No macrovascular tumor invasion (NB: portal vein and/or hepatic vein occlusion from the external tumor compression and classified as "encasement" could be considered after expert radiology review) * No extrahepatic spread * Disease stability for at least 6 months * CA 19-9 \< 200 u/ml at transplant listing in absence of jaundice * No medical and surgical contraindications to liver transplantation * Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1 * No concomitant malignancies or history of other malignancies in the previous 5 years * Written informed consent Exclusion Criteria: * Hilar and distal cholangiocarcinoma * Progression of disease under chemotherapy +/- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria * Evidence of lymph-nodal metastases * Evidence of extrahepatic disease * Prior extrahepatic metastatic disease * Concomitant malignancies or history of other malignancies in the previous 5 years * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Any reason why, in the opinion of the investigator, the patient should not participate to the study