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
Azienda Sanitaria Ospedaliera
Lead sponsor
Azienda Ospedaliera di Padova
Sponsor institution
Istituto Oncologico Veneto IRCCS
Collaborator