Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments

Korábbi kezelés

• Prior extrahepatic metastatic disease

Más betegség

• Progression of disease under chemotherapy +/- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria
• Evidence of extrahepatic disease
• Concomitant malignancies or history of other malignancies in the previous 5 years
• Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

Egyéb

• Hilar and distal cholangiocarcinoma
• Evidence of lymph-nodal metastases
• Any reason why, in the opinion of the investigator, the patient should not participate to the study

• Histological diagnosis of iCCA (biopsy-proven tumor)
• Either first diagnosis or post-resection recurrence (occurring ≥ 6 months after resection)
• Unresectability assessment due to tumor location (leading to insufficient live remnant with/out implementation of hypertrophic parenchymal techniques) or underlying liver disease. Non-resectability assessed by an expert surgical team with experience on both resection and transplantation (centralized at INT Milan).
• Age between 18 and 70 years
• No macrovascular tumor invasion (NB: portal vein and/or hepatic vein occlusion from the external tumor compression and classified as "encasement" could be considered after expert radiology review)
• No extrahepatic spread
• Disease stability for at least 6 months
• CA 19-9 < 200 u/ml at transplant listing in absence of jaundice
• No medical and surgical contraindications to liver transplantation
• Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1
• No concomitant malignancies or history of other malignancies in the previous 5 years
• Written informed consent