Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study.
Launched by HOSPITAL VALL D'HEBRON · May 4, 2020
Trial Information
Current as of August 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for patients with a type of liver cancer called unresectable hilar cholangiocarcinoma (hCCA), which means the cancer cannot be surgically removed. The trial focuses on patients aged 70 or younger who have tumors that are 3 cm or smaller and do not show signs of spreading to lymph nodes or other parts of the body. Participants will receive a combination of chemotherapy and radiation therapy before undergoing a liver transplant. The main goal of the study is to see how long patients survive after the transplant, and other goals include understanding how many patients remain cancer-free and the overall success rate of the transplants.
To be eligible for this trial, patients need to be willing to provide consent and have a good performance status (meaning they are generally well and able to carry out daily activities). However, patients who have had previous cancer treatments outside of this study, or those with cancer that has spread, are not eligible. The trial is currently recruiting participants, and anyone who qualifies can expect to undergo thorough evaluations and receive specialized care throughout the treatment process. This study aims to provide hope for patients with this challenging diagnosis by exploring a potentially effective treatment pathway.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Willing and able to provide written consent form
- • Age ≤ 70 years-old
- • ECOG 0 or 1
- • Unresectable hCCA ≤3cm in radial diameter
- Exclusion Criteria:
- • 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.
- • Infection no controlled
About Hospital Vall D'hebron
Hospital Vall d'Hebron is a leading healthcare institution located in Barcelona, Spain, renowned for its commitment to advancing medical research and patient care. As a prominent clinical trial sponsor, the hospital integrates cutting-edge research with clinical practice, facilitating innovative treatment solutions across various medical specialties. With a multidisciplinary team of experts and state-of-the-art facilities, Hospital Vall d'Hebron is dedicated to improving health outcomes through rigorous clinical studies, actively contributing to the development of new therapies and enhancing evidence-based medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Patients applied
Trial Officials
Cristina Dopazo
Principal Investigator
HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA
Ramón Charco-Torra
Principal Investigator
HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA
Sonia Pascual-Bartolomé
Study Chair
HOSPITAL GENERAL UNIVERSITARIO, ALICANTE
Carmelo Loinaz-Segurola
Study Chair
HOSPITAL UNIVERSITARIO 12 DE OCTUBRE, MADRID
José María Álamo-Martinez
Study Chair
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO, SEVILLA
José Luis Lucena de la Poza
Study Chair
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO, MAJADAHONDA
Arturo Colon-Rodríguez
Study Chair
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON, MADRID
Diego López-Segarra
Study Chair
COMPLEJO HOSPITALARIO UNIVERSITARIO, BADAJOZ
Yilliam Fundora-Suárez
Study Chair
Hospital Clinic of Barcelona
Andrea Bosca-Robledo
Study Chair
Hospital Universitario La Fe
Juan Andrés Echeverri-Cifuentes
Study Chair
HOSPITAL UNIVERSITARIO MARQUES DE VALDECILLA, SANTANDER
Josefina López-Domínguez
Study Chair
HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA
Xavier Merino-Casabiel
Study Chair
HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA
David Leiva-Pedraza
Study Chair
HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA
María Teresa Salcedo-Allende
Study Chair
HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA
José Antonio Gracia Solanas
Study Chair
HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA, ZARAGOZA
Manuel Angel Barrera-Gómez
Study Chair
HOSPITAL UNIVERSITARIO NUESTRA SEÑORA DE LA CANDELARIA, TENERIFE
Ricardo Robles-Campos
Study Chair
Hospital Universitario Virgen de la Arrixaca
Laura Lladó-Garrida
Study Director
HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA
María Teresa Macarulla-Mercadé
Study Director
HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA
Begoña Navalpotro-Yagüe
Study Director
HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA
Florian Castet
Study Chair
HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA
Julio Santoyo
Study Chair
HOSPITAL REGIONAL UNIVERSITARIO DE MALAGA
Manuel Durán Martínez
Study Chair
HOSPITAL UNIVERSITARIO REINA SOFIA DE CÓRDOBA
Natalia Zambudio
Study Chair
Hospital Virgen de las Nieves (Granada)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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