Actively Recruiting
LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
Led by Azienda Sanitaria Ospedaliera · Updated on 2026-04-03
50
Participants Needed
1
Research Sites
511 weeks
Total Duration
On this page
Sponsors
A
Azienda Sanitaria Ospedaliera
Lead Sponsor
I
Istituto Oncologico Veneto IRCCS
Collaborating Sponsor
AI-Summary
What this Trial Is About
LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.
CONDITIONS
Official Title
LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of perihilar cholangiocarcinoma confirmed by biopsy, brush cytology, CA 19-9 levels above 100 mg/mL, imaging, or biliary ploidy with malignant stricture on cholangiography
- Unresectable tumor above the cystic duct or resectable pCCA arising in primary sclerosing cholangitis
- No major vascular invasion, extrahepatic disease, or regional lymph node involvement
- No extrahepatic metastatic disease
- Tumor diameter 3 cm or less
- At least six months elapsed since first diagnosis of pCCA
- Completed at least six months of standard chemotherapy with disease stability or partial response
You will not qualify if you...
- Uncontrollable infection
- Prior radiotherapy or chemotherapy before study
- Previous biliary surgical resection or attempted surgery
- Tumor diameter greater than 3 cm
- Presence of intra-hepatic metastases or intrahepatic cholangiocarcinoma
- Current or past extrahepatic metastatic disease
- Transperitoneal biopsy including percutaneous ecography-guided fine needle aspiration
- Prior cancers except those treated curatively more than 5 years ago without recurrence
- Substance abuse or medical, psychological, or social issues interfering with participation
- Pregnant or breastfeeding women
- Medical or surgical conditions preventing liver transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Azienda Ospedale Università di Padova
Padova, PADOVA, Italy, 35128
Actively Recruiting
Research Team
E
Enrico Gringeri, Prof.
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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