Actively Recruiting
Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study.
Led by Hospital Vall d'Hebron · Updated on 2025-09-09
34
Participants Needed
1
Research Sites
370 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable hilar cholangiocarcinoma (hCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radio-chemotherapy will be performed in this selected group. The primary endpoint will be overall survival at 1, 3, and 5 years post-transplant. The secondary endpoints will be: 1) recurrence free survival at 1, 3 and 5 years post-transplant; 2) intention-to-treat survival of overall patients included in the study at 1,3 and 5 year; 3) the rate of patients included in the study who are finally transplanted.
CONDITIONS
Official Title
Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written consent form
- Age 70 years or younger
- ECOG performance status of 0 or 1
- Unresectable hilar cholangiocarcinoma measuring 3 cm or less in diameter
You will not qualify if you...
- Prior chemotherapy or radiotherapy outside this study protocol
- Presence of liver, extrahepatic, or lymph node metastases
- Previous attempt or intent of surgical resection or percutaneous biopsy
- Previous or concurrent cancer different from adenocarcinoma at the primary site, except certain treated localized cancers
- Uncontrolled infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
C
CRISTINA DOPAZO, 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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