Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)

Exclusion Criteria

• •No vascular invasion, extrahepatic disease, or lymph node involvement detected on imaging
• •No signs of extrahepatic metastatic disease according to positron emission computed tomography (PET-CT) scan
• •Patient must be accepted for transplantation before progressive disease on chemotherapy.
• •Twelve months or more time span from the diagnosis of iCCA and date of being listed for liver transplantation
• •No signs of extrahepatic metastatic disease according to CT or magnetic resonance (MR) scan within 4 weeks prior to the faculty meeting at the transplant unit
• •At least 18 years of age
• •Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1
• •Signed informed consent and expected cooperation of the patients for the treatment and follow up
• •Received at least 6 months of chemotherapy or locoregional therapy
• •Major vascular involvement of the tumor
• •Perforation of the visceral peritoneum
• •Weight loss \>15% the last 6 months
• •Patient BMI \> 30
• •Other malignancies, except curatively treated more than 5 years ago without relapse
• •Known history of human immunodeficiency virus (HIV) infection
• •Prior history of solid organ or bone marrow transplantation
• •Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• •Known hypersensitivity to rapamycin
• •Prior extrahepatic metastatic disease
• •Women who are pregnant or breast feeding
• •Any reason why, in the opinion of the investigator, the patient should not participate