LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)

Inclusion Criteria12

• 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