Actively Recruiting
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
Led by Oslo University Hospital · Updated on 2025-07-31
15
Participants Needed
1
Research Sites
1239 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 Perihilar Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radiologically strong suspicion of perihilar cholangiocarcinoma (pCCA)
- Tumor may involve intrahepatic portal vein without thrombosis of extrahepatic portal vein
- Tumor may involve hepatic artery distal to gastroduodenal artery or replaced hepatic artery
- First occurrence of pCCA
- Disease not eligible for liver resection due to tumor location or liver dysfunction
- No extrahepatic disease or lymph node involvement seen on imaging
- No signs of extrahepatic metastatic disease on PET-CT
- No signs of extrahepatic metastatic disease on CT or MRI scans within 4 weeks before transplant evaluation
- Age 18 years or older
- Good performance status (ECOG score 0 or 1)
- Blood tests within acceptable ranges: Hemoglobin >10 g/dl, neutrophils >1.0, platelets >50, bilirubin less than 3 times upper normal limit, ASAT and ALAT less than 5 times upper normal limit, creatinine less than 1.5 times upper normal limit, albumin normal, normal IgG4 levels
- Signed informed consent and willingness to cooperate with treatment and follow-up
- Received chemotherapy for at least 6 months with at least 10% response per RECIST criteria and no disease progression at time of liver transplantation
- At least 10 months since diagnosis
- Accepted for transplantation before disease progression
- At least 12 months from diagnosis to listing for liver transplantation
You will not qualify if you...
- Tumor involving common hepatic artery, celiac trunk, or superior mesenteric artery
- Tumor involving main portal vein
- Tumor involving inferior vena cava
- Perforation of the visceral peritoneum
- Weight loss greater than 15% in the last 6 months
- Body mass index (BMI) greater than 30
- Other malignancies unless curatively treated more than 5 years ago without relapse
- Known HIV infection
- Prior solid organ or bone marrow transplantation
- Substance abuse or medical, psychological, or social conditions interfering with participation or evaluation
- Known hypersensitivity to rapamycin
- Prior extrahepatic metastatic disease
- Women who are pregnant or breastfeeding
- Any condition that, in the investigator's opinion, contraindicates participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo university hospital
Oslo, Norway
Actively Recruiting
Research Team
S
Sheraz Yaqub, MD PhD
CONTACT
P
Pål-Dag Line, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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