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

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.

Conditions

• Unresectable Cholangiocarcinoma

Interventions

DRUG

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.

PROCEDURE

Liver Transplantation

If no spread disease is discovered after neoadjuvant treatment, the patient will be listed for liver transplantation.

Sponsors & Collaborators

• Hospital Vall d'Hebron

  lead OTHER

Principal Investigators

• Sonia Pascual-Bartolomé · HOSPITAL GENERAL UNIVERSITARIO, ALICANTE

• Carmelo Loinaz-Segurola · HOSPITAL UNIVERSITARIO 12 DE OCTUBRE, MADRID

• José María Álamo-Martinez · HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO, SEVILLA

• José Luis Lucena de la Poza · HOSPITAL UNIVERSITARIO PUERTA DE HIERRO, MAJADAHONDA

• Arturo Colon-Rodríguez · HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON, MADRID

• Diego López-Segarra · COMPLEJO HOSPITALARIO UNIVERSITARIO, BADAJOZ

• Yilliam Fundora-Suárez · Hospital Clinic of Barcelona

• Eva Montalvá-Orón · Hospital Universitario La Fe

• Juan Andrés Echeverri-Cifuentes · HOSPITAL UNIVERSITARIO MARQUES DE VALDECILLA, SANTANDER

• María Teresa Salcedo-Allende · HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA

• José Antonio Gracia Solanas · HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA, ZARAGOZA

• Adriá Rosat-Rodrigo · HOSPITAL UNIVERSITARIO NUESTRA SEÑORA DE LA CANDELARIA, TENERIFE

• Victor Lopez-Lopez · Hospital Universitario Virgen de la Arrixaca

• Laura Lladó-Garrida · HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA

• María Teresa Macarulla-Mercadé · Hospital Clinic of Barcelona

• Begoña Navalpotro-Yagüe · HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA

• Jaume Capdevila · HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA

• Julio Santoyo · HOSPITAL REGIONAL UNIVERSITARIO DE MALAGA

• Manuel Durán Martínez · HOSPITAL UNIVERSITARIO REINA SOFIA DE CÓRDOBA

• Natalia Zambudio · Hospital Virgen de las Nieves (Granada)

• Mikel Gastaka · Hospital Universitario de Cruces

• Manuel Abradelo · Hospital Universitario de Toledo

• Dora Gómez-Pasantes · Complejo Hospitalario Universitario, A Coruña

• Carmen Bernardo · Hospital Universitario Central de Asturias

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-24

Primary Completion

2027-06-01

Completion

2027-06-01

Countries

• Spain

Study Locations