Actively Recruiting
Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-05-23
8
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (SBRT).
CONDITIONS
Official Title
Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter 3 cm, diagnosed by:
- Transcatheter biopsy or brush cytology
- CA-19.9 > 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography
- Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
- Age between 18 years and 70 years
- Absence of intra- and extrahepatic metastases
- Absence of lymph-nodal metastases at any site
- Biliary stenting of all liver districts
- No contraindications to liver transplantation
- No concomitant malignancies or history of other malignancies in the previous 5 years
- Written informed consent
You will not qualify if you...
- Intrahepatic cholangiocarcinoma
- Uncontrolled infection
- Concomitant malignancies or history of other malignancies in the previous 5 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Michigan, Italy, 20133
Actively Recruiting
Research Team
V
Vincenzo Mazzaferro, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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