LIRICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable iCCA after a downstaging/disease control protocol 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-MR, especially in relation to lymph node locations, by correlating the results with histological examination after iliac lymphadenectomy.
Histologically confirmed diagnosis of iCCA
First diagnosis of iCCA
Recurrence after R0 hepatic resection, N0, M0 without macrovascular invasion
Disease considered unsuitable for hepatic resection based on tumor location and extent or underlying liver dysfunction
Tumor involving nearby extrahepatic structures (including involvement of major hepatic vessels) by direct invasion (T4 per AJCC 8th edition)
Tumor penetrating the visceral peritoneum (T3 per AJCC 8th edition)
Previous extrahepatic metastatic disease
Prior neoplasms, except those treated curatively for more than 5 years without recurrence
Single group
Liver transplantation
Procedure/SurgeryPatients 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
Survival from time of transplantation to time of death or last follow up
OS comparison with chemotherapy alone
Comparison of 3-year survival between patients enrolled in the LIRICA study and survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV)
Disease-Free Survival (DFS)
Survival from time of transplantation to time of death or first evidence of recurrence fo disease
Overall survival from the time of recurrence
Survival from time of recurrence to time of death or last follow up
PFS comparison with chemotherapy alone
Comparison of 3-year Progression-Free Survival (PFS) between the per-protocol population of patients enrolled in the LIRICA study and the PFS of the population from the Veneto Oncological Institute (IOV) database
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Azienda Sanitaria Ospedaliera
Lead sponsor
Azienda Ospedaliera di Padova
Sponsor institution
Istituto Oncologico Veneto IRCCS
Collaborator
