Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA
This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (SBRT).
• Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:
• 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
• Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
• Age between 18 years and 70 years
• Absence of intra- and extrahepatic metastases
• Absence of lymph-nodal metastases at any site
• Biliary stenting of all liver districts
• No contraindications to liver transplantation
• No concomitant malignancies or history of other malignancies in the previous 5 years
• Written informed consent