This is single-arm, observational, academic, investigator-driven study investigating the efficacy of liver transplantation after successful and sustained downstaging/tumor control of liver-limited unresectable intrahepatic cholangiocarcinoma. The downstaging protocol includes chemotherapy +/- immunotherapy and transarterial radioembolization (TARE) with Yttrium-90 in various combinations.
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
Hilar and distal cholangiocarcinoma
Progression of disease under chemotherapy +/- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria
Evidence of lymph-nodal metastases
Evidence of extrahepatic disease
Patients with unresectable liver-limited intrahepatic cholangiocarcinoma with no non-oncological contraindications to liver transplantation
Cohort
Prospective
Not listed
3-year overall survival vs unresectable patients
OS at 3 years after liver transplant will be matched and compared with OS of patients with similar characteristics that were not offered LT, taken from an institutional historical series and from patients found not eligible to LT due to medical/non-oncological conditions
3-year recurrence-free survival vs unresectable patients
To evaluate the time to recurrence after LT in patients with unresectable iCCA, RFS at 3 years after LT will be matched and compared with time to progression of patients with similar characteristics that were not offered LT, taken from an institutional historical series and from patients found non-eligible to LT due to medical/non-oncological conditions
90-day morbidity
The safety of chemotherapy +/- immunotherapy, locoregional treatments and liver transplatation in patients with unresectable iCCA will be assessed with the Clavien-Dindo classification and the Comprehensive Complication Index
Quality of life
The impact of this treatment strategy and of LT on quality of life in patients with unresectable iCCA will be assessed with validated questionnaires. Questionnaires will be performed at baseline and at 6 months intervals; they will be matched and compared with that of eligible patients recruited within the same study period and receiving non-transplant treatments.
3-year OS vs resectable patients
OS after LT in patients with unresectable iCCA will be compared with OS of patients with similar characteristics, but with resectable tumors, who underwent surgical resection during the same time period
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