RecruitingNCT04378023

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


Sponsor

Hospital Vall d'Hebron

Enrollment

34 participants

Start Date

Apr 24, 2020

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether liver transplantation combined with chemotherapy and radiation therapy (given before transplant) can treat a type of bile duct cancer called hilar cholangiocarcinoma that cannot be surgically removed in the usual way. The goal is to see if transplant offers a cure for patients who would otherwise have no surgical options. **You may be eligible if...** - You are 70 or younger - You have unresectable hilar cholangiocarcinoma (bile duct cancer at the junction of the liver) with a tumor no more than 3 cm wide - Your overall health is good (ECOG 0-1) - You are willing to provide written consent **You may NOT be eligible if...** - You have already received chemotherapy or radiation outside of this protocol - Your cancer has spread to lymph nodes or other organs - You previously had attempted surgical removal or a percutaneous (needle through skin) biopsy of the tumor - You have another active cancer - You have an uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant 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.

PROCEDURELiver 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, Barcelona, Spain

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NCT04378023