Liver transplantation for patients with non-resectable bile duct cancer
Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
This study is testing if liver transplantation can help people with inoperable bile duct cancer live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oslo) |
| Trial ID | NCT04556214 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed intrahepatic cholangiocarcinoma who are not eligible for surgical resection due to tumor location or liver dysfunction.
Not a fit: Patients with extrahepatic metastatic disease or significant vascular invasion will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival and quality of life for patients with advanced bile duct cancer.
How similar studies have performed: While liver transplantation for cholangiocarcinoma is a novel approach, similar studies have shown promising results in select patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Oslo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.