Liver Transplant for Bile Duct Cancer That Cannot Be Removed by Surgery

Trial details

Who runs it

Oslo University Hospital

Trial code

NCT04993131

Record updated

16 October 2026

Original description

The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated.Read full original descriptionShow less

Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma: a Prospective Exploratory Trial

The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated.

Inclusion: Radiologically strong suspicion of pCCA; Tumor can involve intrahepatic portal vein without thrombosis of extrahepatic portal vein; Tumor can involve hepatic artery distal to gastroduodenal artery or involve replaced hepatic artery; First time pCCA; Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction; No extrahepatic disease, or lymph node involvement detected on imaging; No signs of extrahepatic metastatic disease according to PET-CT scan; No signs of extrahepatic metastatic disease according to CT or MR (chest/abdomen/pelvis) 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) score: 0 or 1; Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >50, Bilirubin<3 x upper normal level, ASAT, ALAT<5 x upper normal level, Creatinine <1.5 x upper normal level. Albumin above lower normal level, Normal IgG4 levels; Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations; Received chemotherapy for at least 6 months with at least 10% response according ti RECIST criteria and with no progression of disease at time of Lt; At least 10 months from diagnosis; Patient must be accepted for transplantation before progressive disease; Twelve months or more time span from the diagnosis of pCCA and date of being listed for liver transplantation.

Exclusion: Prior history of solid organ or bone marrow transplantation; Prior extrahepatic metastatic disease; Perforation of the visceral peritoneum; Other malignancies, except curatively treated more than 5 years ago without relapse; Known history of human immunodeficiency virus (HIV) infection; 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; Tumor involving common hepatic artery, celiac trunck or superior mesenteric artery the tumor; Tumor involving main portal vein; Tumor involving inferior vena cava; Weight loss >15% the last 6 months; Patient BMI > 30; Women who are pregnant or breast feeding; Any reason why, in the opinion of the investigator, the patient should not participate.

ClinicalTrials.gov NCT04993131