Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study.

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Willing and able to provide written consent form

• Age ≤ 70 years-old

• ECOG 0 or 1

• Unresectable hCCA ≤3cm in radial diameter

Locations
Other Locations
Spain
Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
RECRUITING
Barcelona
Contact Information
Primary
CRISTINA DOPAZO, MD/PhD
cristina.dopazo@vallhebron.cat
+34932746113
Time Frame
Start Date: 2020-04-24
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 34
Treatments
Study group
Patients with unresectable hilar cholangiocarcinoma (hCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases
Sponsors
Leads: Hospital Vall d'Hebron

This content was sourced from clinicaltrials.gov