Actively Recruiting
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma (LITALHICA)
Led by Azienda Sanitaria Ospedaliera · Updated on 2026-04-03
50
Participants Needed
1
Research Sites
260 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
Researchers are evaluating liver transplantation outcomes in patients with unresectable perihilar cholangiocarcinoma (pCCA) who have undergone standard chemotherapy. The study aims to assess overall survival and quality of life after transplantation, identify biological and clinical factors that predict better prognosis, and examine the role of preoperative PET-MRI imaging in relation to lymph node involvement. Patients will first receive six months of standard chemotherapy followed by PET-MRI to rule out disease spread outside the liver. Those with stable disease will be listed for liver transplantation, which includes exploratory surgery and lymph node evaluation before the procedure. Transplantation follows institutional protocols and may involve cadaveric or living donor livers, whole or partial. Participants will undergo routine imaging, clinical evaluations, and histological examinations of lymph nodes during surgery. Researchers will monitor survival up to five years, progression-free survival, quality of life using questionnaires, cancer-related mortality, and postoperative complications. The study includes long-term follow-up to compare outcomes with chemotherapy alone and to validate imaging and biological markers.
CONDITIONS
Brief 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 or imaging
- Unresectable tumor above the cystic duct or resectable pCCA arising in primary sclerosing cholangitis
- No major vascular invasion, no extrahepatic disease, and no regional lymph node involvement
- No extrahepatic metastatic disease
- Tumor diameter 3 cm or less
- At least six months 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
- Prior biliary surgery or attempted surgical resection
- Tumor diameter greater than 3 cm
- Presence of intra-hepatic metastases or intrahepatic cholangiocarcinoma
- Past or present extrahepatic metastatic disease
- Transperitoneal biopsy including percutaneous ultrasound-guided fine needle aspiration
- Previous cancers except those cured 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 contraindications to liver transplantation
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 - 6 months
Participants receive 6 months of standard of care chemotherapy and undergo radiological studies to assess disease status and eligibility for liver transplantation.
Regular visits during chemotherapy and imaging assessments
Duration - Variable until transplantation
Participants with stable disease after chemotherapy are listed for liver transplantation and continue chemotherapy until a compatible liver becomes available.
Visits as needed during waiting period
Duration - Hospital stay duration for surgery and immediate care
Participants undergo liver transplantation preceded by exploratory laparotomy and surgical nodal staging according to institutional protocols.
1 surgical hospitalization
Duration - Up to 5 years
Participants are monitored for post-operative recovery, survival, disease progression, and quality of life.
Follow-up visits scheduled according to institutional protocols
Trial Site Locations
Total: 1 location
1
Azienda Ospedale Università di Padova
Padova, PADOVA, Italy, 35128
Actively Recruiting
Research Team
E
Enrico Gringeri, Prof.
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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