A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radiochemotherapy will be performed in this selected group.
The primary endpoint will be overall survival at 1, 3, and 5 years post-transplant. The secondary endpoints will be: 1) recurrence-free survival at 1, 3 and 5 years post-transplant; 2) intention-to-treat survival of all patients included in the study at 1,3 and 5 years; 3) the rate of patients included in the study who are finally transplanted.
Willing and able to provide written consent form
Age ≤ 70 years-old
ECOG 0 or 1
Unresectable hCCA ≤3cm in radial diameter
Those patients who have received chemotherapy or radiotherapy previously out of protocol
Liver, extrahepatic or lymph node metastases
Previous intent of surgical resection or percutaneous biopsy
Previous or concurrent cancer that is different in primary site or histology from adenocarcinoma, except cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1). Any cancer curatively treated 5 years prior to entry is permitted.
Those patients with unresectable malignant appearing hilar stricture and at least one of the following: * Malignant cytology or histology * CA 19.9\>130U/mL without cholangits or/and jaundice * Mass on cross-sectional imaging
Cohort
Prospective
Neoadjuvant Chemo-radiotherapy
DrugPatients will receive neoadjuvant radiotherapy (External - 50-54 grays) following by concomitant oral capecitabine (825mg/m2 bid).Thereafter, gemcitabine iv (1000mg/m2) plus cisplatin iv (25mg/m2) will be administered the day 1 and 8 every 21 days until transplant.
Liver Transplantation
Procedure/SurgeryIf no spread disease is discovered after neoadjuvant treatment, the patient will be listed for liver transplantation.
Overall survival at 1, 3, and 5 years post-transplant
Recurrence free survival at 1, 3 and 5 years post-transplant
Intention-to-treat survival of overall patients included in the study at 1,3 and 5 year
The rate of patients included in the study who are finally transplanted.
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