Liver transplantation for patients with non-resectable bile duct cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the potential benefits of liver transplantation for patients with intrahepatic cholangiocarcinoma that cannot be surgically removed. It aims to determine if this approach can improve survival rates, minimize side effects, and enhance quality of life. The study will also analyze blood and tissue samples to identify markers that may predict disease recurrence post-transplant. Additionally, the effects of chemotherapy on liver tissues will be examined during the transplantation process.

Why it matters

Who can join: the full rules

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

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Principal investigator: Magnus Smedman, MD — Oslo University Hospital
• Study coordinator: Magnus Smedman, MD
• Email: torha@ous-hf.no
• Phone: 23026600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.