Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Perihilar Cholangiocarcinoma. A Prospective Multicenter Study.
Hospital Vall d'Hebron
34 participants
Apr 24, 2020
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Patients 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.
If no spread disease is discovered after neoadjuvant treatment, the patient will be listed for liver transplantation.
Locations(1)
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NCT04378023