Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma

Launched by OSLO UNIVERSITY HOSPITAL · Aug 5, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on exploring the potential benefits of liver transplantation for patients with perihilar cholangiocarcinoma, a type of bile duct cancer that cannot be removed through regular surgery. Researchers want to see if this procedure can help patients live longer, experience fewer side effects, and maintain a good quality of life. They will also study blood and tissue samples to find out if these tests can predict whether the cancer might return after the transplant. Additionally, the impact of chemotherapy on the liver and tumor tissues removed during the transplant will be examined.

To participate in this trial, patients should be at least 18 years old and have a strong suspicion of bile duct cancer that hasn't spread outside the liver. They must have received chemotherapy for at least six months with some positive response. Other criteria include having good overall health and specific blood test results. Participants will be closely monitored throughout the process, and their cooperation is essential for both treatment and follow-up. It’s important for potential participants to understand that this trial may offer a new treatment option for a challenging condition, but they should also discuss any questions or concerns with their healthcare provider.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 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 criteria
• • Tumor involving common hepatic artery, celiac trunck or superior mesenteric artery the tumor
• • Tumor involving main portal vein
• • Tumor involving inferior vena cava
• • 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