Liver transplant trial for bile duct cancer that cannot be removed by surgery
Tests liver transplantation in adults with bile duct cancer that cannot be removed by surgery.
Plain-language title generated from the registry record
Registry title: Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
Key facts
- Where
- Oslo, NorwaySee the site
Where in Norway
- Oslo University HospitalOslo, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital
- Trial code
- NCT04556214
- Record updated
- 11 April 2023
- 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 Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA 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: Histologically verified diagnosis of Intrahepatic Cholangiocarcinoma (iCCA); First time iCCA or liver only recurrence after previous liver resection for iCCA; Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction; 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.
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; Major vascular involvement of the tumor; 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.