An interventional study of Liver transplantation in Perihilar Cholangiocarcinoma, sponsored by Azienda Sanitaria Ospedaliera. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Azienda Sanitaria Ospedaliera · Not applicable, Interventional, and Treatment
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.
86 studies on the registry are indexed under Klatskin Tumor; 26 are open to participants now.
This study's planned enrollment of 50 is below the median of 56 across 57 interventional studies indexed under Klatskin Tumor.
Browse Klatskin Tumor studies →Azienda Sanitaria Ospedaliera is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Candidates will be evaluated by a National Multidisciplinary Group after routine radiological studies (CT, MRI, PET-MRI/CT). Patients will receive 6 months of standard of care chemotherapy and undergo PET-MRI with FDG to exclude the presence of extrahepatic disease. Following completion of therapy, patients will undergo radiological restaging: those who demonstrate stable disease at this stage are considered eligible for definitive listing for LT. Patients will continue chemotherapy until a compatible liver becomes available. If there are no further contraindications, exploratory laparotomy and surgical nodal staging of the tumor will be performed at the time of transplantation. If there are no signs of extrahepatic disease, transplantation will be conducted according to institutional protocols.
Procedure: 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.
Overall Survival (OS)
Survival from time of transplantation to time of death or last follow up
Time frame: 3 and 5 years
Overall survival comparison with chemotherapy alone
Comparison of 3-year survival between patients enrolled in the LITALHICA study and survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV)
Time frame: 3 years
Progression-Free Survival (PFS)
Survival from time of transplantation to time of death or first evidence of progression of disease
Time frame: 3 and 5 years
Overall survival from the time of recurrence
Survival from time of recurrence to time of death or last follow up
Time frame: 5 years
Progression-free survival comparison with chemotherapy alone
Comparison of 3-year progression-free survival between patients enrolled in the LITALHICA study and progression-free survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV)
Time frame: 3 years
Biological markers
Correlation of overall survival and recurrence with tissue and circulating biological markers (immunohistochemistry, proteomics, circulating tumor cells, circulating tumor DNA, new molecular markers)
Time frame: 5 years
Morbidity
Morbidity at 90 days (according to Clavien-Dindo and Comprehensive Complication Index, CCI)
Time frame: 90 days
Cancer-related mortality
Risk of mortality with sole relation to death by tumor progression
Time frame: 3 and 5 years
Drop out
Percentage of patients who do not complete the procedure (drop-out) stratified by cause
Time frame: 5 years
Concordance of surgical and PET/MRI staging
Asses if lymph nodes described as suspicious at the preoperative PET-MRI confirm to be pathological at the histological evaluation after lymphadenectomy of the hepatic hilum and exploratory laparotomy
Time frame: Perioperative
Quality of life assessed using EORTC QLQ-C30
Quality of life assessed using EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer QLQ Core Questionnaire) 30 items questionnaire (scale 1-4 or 1-7, 1 being the lowest and 4 or 7 the highest, accordingly)
Time frame: 5 years
Quality of life assessed using FACT-Hep questionnaire
Quality of life assessed using FACT-Hep questionnaire (Functional Assessment of Cancer Therapy - Hepatobiliary) questionnaire about quality of life in the last 7 days (scale 0-4, 0 being the lowest and 4 the highest)
Time frame: 5 years
Plan to share: No
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Azienda Sanitaria Ospedaliera