NCT06125769 LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief 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 Criteria

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 extrah

Related Trials