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

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.

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

• Cristina Dopazo · HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA

• Ramón Charco-Torra · HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA

• 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

• Andrea Bosca-Robledo · Hospital Universitario La Fe

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

• Marina Vila-Tura · HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA

• Xavier Merino-Casabiel · HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA

• David Leiva-Pedraza · HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA

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

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

• Manuel Angel Barrera-Gómez · HOSPITAL UNIVERSITARIO NUESTRA SEÑORA DE LA CANDELARIA, TENERIFE

• Ricardo Robles-Campos · Hospital Universitario Virgen de la Arrixaca

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

• María Teresa Macarulla-Mercadé · HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA

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

• Florian Castet · 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)

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