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

RecruitingNAAges 18 Years - anyAllOslo University Hospital
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In plain words

What the trial is, and whether it could suit you

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..

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Liver Transplant
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Where

1 site
Oslo University Hospital
Oslo, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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