LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)

NCT06125769 · tracked via the Priya Life Science Italy tracker

Sponsor

Azienda Sanitaria Ospedaliera

Phase

Not applicable

Started

2024-01-15

Last updated

2026-04-03

Condition(s) studied

Perihilar Cholangiocarcinoma

Investigational drug(s) / intervention(s)

Liver transplantation

Liver transplantation: Patients will undergo liver transplantation according to the standard procedures of the institutional Center's protocol (cadaveric or living donor transplantation, whole or partial liver). Liver transplantation is preceded by an exploratory laparotomy with clinical evaluation and frozen section examination of lymph nodes in the hepatoduodenal ligament and along the common hepatic artery/celiac axis.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Diagnosis of pCCA (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, or biliary ploidy with a malignant appearing stricture on cholangiography) * Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC * Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes * No extrahepatic metastatic disease * Radial tumor diameter ≤3 cm * At least six months between first diagnosis of pCCA and date of inclusion * At least six months of SOC chemotherapy, achieving disease stability or partial response Exclusion Criteria: * Uncontrollable infection * Prior radiotherapy or chemotherapy * Prior biliary surgical resection or attempted surgical resection * Diameter of tumor \>3cm * Presence of intra-hepatic metastases or iCCA * Present or past evidence of extrahepatic metastatic disease * Transperitoneal biopsy (including percutaneous ecography-guided FNA) * Prior neoplasms, except those treated curatively for more than 5 years without recurrence * Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study * Pregnant or breastfeeding women * Medical-surgical contraindications for liver transplantation

Primary outcome measure(s)

Overall Survival (OS) — 3 and 5 years
Survival from time of transplantation to time of death or last follow up

Trial sites (1)

Facility	City	Region	Status
Azienda Ospedale Università di Padova	Padova	PADOVA	Recruiting

More Azienda Sanitaria Ospedaliera trials in Italy

LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA) Recruiting

Other trials for the same condition

Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma Recruiting

Robotically Assisted Surgery For Perihilar Cholangiocarcinoma: A Prospective Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06125769 on ClinicalTrials.gov ↗ ← All trials in Italy