LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)

Inclusion Criteria: Histologically confirmed diagnosis of iCCA First diagnosis of iCCA Recurrence after R0 hepatic resection, N0, M0 without macrovascular invasion Disease considered unsuitable for hepatic resection based on tumor location and extent or underlying liver dysfunction Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes detected on radiological study No evidence of extrahepatic metastatic disease after chest-abdomen-pelvis CT and PET-MR (or PET-CT) At least six months have passed since the first diagnosis of iCCA (or recurrence) to the date of inclusion on the liver transplant waiting list The patient has received at least six months of SOC chemotherapy, achieving disease stability or partial response (according to RECIST version 1.1) at the time of listing for transplantation Hematochemical evaluation: Hb ≥ 9 g/dL, Leukocytes ≥ 3.0 X 109/L, Neutrophils ≥ 1.5 X 109/L, Platelets ≥ 100,000/mm3 (≥ 10 X 109/L), Total Bilirubin ≤ 3 mg/dL (≤ 51 umol/L), AST or ALT ≤ 5 times the upper limit of normal, Serum Creatinine and Urea < 1.5 times the upper limit of normal ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 Patient's BMI ≥ 18 and ≤ 30 kg/m2 Signed informed consent, and expected patient cooperation for treatment and follow-up, must be obtained and documented according to good clinical practice and national/local regulations Exclusion Criteria: Tumor involving nearby extrahepatic structures (including involvement of major hepatic vessels) by direct invasion (T4 per AJCC 8th edition) Tumor penetrating the visceral peritoneum (T3 per AJCC 8th edition) Previous extrahepatic metastatic disease Prior neoplasms, except those treated curatively for more than 5 years without recurrence Known history of human immunodeficiency virus (HIV) infection Known history of solid organ or bone marrow transplantation Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study or with the evaluation of study outcomes Pregnant or breastfeeding women Medical-surgical contraindications for liver transplantation Any reason for which, in the investigator's judgment, the patient should not participate in the study