Actively Recruiting
Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
Led by Oslo University Hospital · Updated on 2023-04-11
15
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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..
CONDITIONS
Official Title
Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed intrahepatic cholangiocarcinoma (iCCA)
- First occurrence of iCCA or liver-only recurrence after prior liver surgery for iCCA
- Tumor not suitable for surgical removal based on location or liver function
- No vascular invasion, extrahepatic disease, or lymph node involvement on imaging
- No extrahepatic metastases on PET-CT scan
- Accepted for liver transplantation before disease progression on chemotherapy
- At least 12 months between iCCA diagnosis and listing for transplantation
- No extrahepatic metastases on CT or MRI within 4 weeks before transplant evaluation
- Age 18 years or older
- Good performance status (ECOG 0 or 1)
- Signed informed consent and willingness to cooperate with treatment and follow-up
- Received at least 6 months of chemotherapy or locoregional therapy
You will not qualify if you...
- Major blood vessel involvement by tumor
- Perforation of the visceral peritoneum
- Weight loss greater than 15% in the last 6 months
- Body mass index (BMI) over 30
- Other cancers unless cured over 5 years ago without relapse
- Known HIV infection
- History of organ or bone marrow transplantation
- Substance abuse or medical, psychological, or social conditions interfering with participation
- Known allergy to rapamycin
- Prior extrahepatic metastatic disease
- Pregnancy or breastfeeding
- Any condition making participation unsuitable in investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0451
Actively Recruiting
Research Team
M
Magnus Smedman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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