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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorHospital Vall d'Hebron

About this trial

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 criteria

Qualifiers

Willing and able to provide written consent form

Age ≤ 70 years-old

ECOG 0 or 1

Unresectable hCCA ≤3cm in radial diameter

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Neoadjuvant Chemo-radiotherapy
  • Liver Transplantation

Treatment groups

34 Participants
are divided into 1 treatment group

Sponsors and collaborators