Actively Recruiting
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma: a Prospective Exploratory Trial
Led by Oslo University Hospital · Updated on 2025-07-31
15
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating liver transplantation as a treatment option for patients with bile duct cancer (perihilar cholangiocarcinoma) when the tumor cannot be removed by regular surgery. The study aims to assess whether liver transplantation improves survival, has low side effects, and maintains good quality of life. Blood and tumor tissue samples will be analyzed to identify markers that might predict disease recurrence after transplantation. Additionally, the impact of chemotherapy on normal liver and tumor tissues removed during transplantation will be examined. Patients in this study will undergo liver transplantation following standard procedures performed by a specialized surgical team. The surgery involves an exploratory operation to assess lymph nodes and clear lymphatic tissues around key blood vessels to ensure no disease spread that would prevent transplantation. This study includes only patients with tumors that meet specific criteria and who have received chemotherapy with stable disease before transplantation. Participants will be monitored closely with evaluations of overall survival up to 36 months from screening, disease-free survival up to 10 years after transplantation, quality of life assessments, and tracking of complications. Researchers will also study survival related to biological markers and record any new malignancies over a long-term follow-up. The study requires signed consent and cooperation for treatment and follow-up visits, with ongoing assessments of blood tests and imaging to monitor health and disease status.
CONDITIONS
Brief 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 time diagnosis of pCCA
- Disease not eligible for liver resection due to tumor location or liver dysfunction
- No extrahepatic disease or lymph node involvement detected on imaging
- No signs of extrahepatic metastasis on PET-CT, CT, or MR scans within 4 weeks prior to evaluation
- At least 18 years old
- Good performance status with Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Satisfactory blood tests including hemoglobin >10 g/dl, neutrophils >1.0, platelets >50, bilirubin <3 times upper normal limit, ASAT and ALAT <5 times upper normal limit, creatinine <1.5 times upper normal limit, albumin above lower normal limit, normal IgG4 levels
- Signed informed consent and expected cooperation for treatment and follow-up
- Received chemotherapy for at least 6 months with at least 10% response per RECIST and no disease progression at transplantation
- At least 10 months since diagnosis
- Accepted for transplantation before disease progression
- At least 12 months between diagnosis and 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 last 6 months
- Body mass index (BMI) over 30
- Other malignancies except those cured 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
- Known hypersensitivity to rapamycin
- Prior extrahepatic metastatic disease
- Pregnant or breastfeeding women
- Any condition deemed by the investigator to contraindicate participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 hours and 20 minutes for surgery; immediate post-operative care duration varies.
Participants undergo liver transplantation surgery performed by specialist surgeons, including an exploratory laparotomy and assessment of lymph nodes to determine transplant eligibility.
1 surgical procedure and immediate hospital care visits
Duration - Up to 10 years after liver transplantation
Participants are monitored for complications, disease-free survival, quality of life, and potential new treatments after liver transplantation.
Regular follow-up visits over several years
Trial Site Locations
Total: 1 location
1
Oslo university hospital
Oslo, Norway
Actively Recruiting
Research Team
S
Sheraz Yaqub, MD PhD
P
Pål-Dag Line, MD PhD
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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