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Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study.
Sponsor: Hospital Vall d'Hebron
Summary
A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable hilar cholangiocarcinoma (hCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radio-chemotherapy 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 overall patients included in the study at 1,3 and 5 year; 3) the rate of patients included in the study who are finally transplanted.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
34
Start Date
2020-04-24
Completion Date
2027-06-01
Last Updated
2025-09-09
Healthy Volunteers
No
Conditions
Interventions
Neoadjuvant Chemo-radiotherapy
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.
Liver Transplantation
If no spread disease is discovered after neoadjuvant treatment, the patient will be listed for liver transplantation.
Locations (1)
Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
Barcelona, Spain