NCT04378023

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Apr 2020Jun 2027

Study Start

First participant enrolled

April 24, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

7.1 years

First QC Date

May 4, 2020

Last Update Submit

September 8, 2025

Conditions

Unresectable Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival at 1, 3, and 5 years post-transplant

    5 years

Secondary Outcomes (3)

  • Recurrence free survival at 1, 3 and 5 years post-transplant

    5 years

  • Intention-to-treat survival of overall patients included in the study at 1,3 and 5 year

    5 years

  • The rate of patients included in the study who are finally transplanted.

    5 years

Study Arms (1)

Study group

Patients with unresectable hilar cholangiocarcinoma (hCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases

Drug: Neoadjuvant Chemo-radiotherapyProcedure: Liver Transplantation

Interventions

Neoadjuvant Chemo-radiotherapyDRUG

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.

Study group
Liver TransplantationPROCEDURE

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

Study group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those patients with unresectable malignant appearing hilar stricture and at least one of the following: * Malignant cytology or histology * CA 19.9\>130U/mL without cholangits or/and jaundice * Mass on cross-sectional imaging

You may qualify if:

  • Willing and able to provide written consent form
  • Age ≤ 70 years-old
  • ECOG 0 or 1
  • Unresectable hCCA ≤3cm in radial diameter

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of HPB Surgery and Transplants, Hospital Vall d´Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (5)

  • Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9. doi: 10.1097/00000658-200110000-00010.

    PMID: 11573044RESULT

  • Heimbach JK, Gores GJ, Haddock MG, Alberts SR, Nyberg SL, Ishitani MB, Rosen CB. Liver transplantation for unresectable perihilar cholangiocarcinoma. Semin Liver Dis. 2004 May;24(2):201-7. doi: 10.1055/s-2004-828896.

    PMID: 15192792RESULT

  • Rea DJ, Heimbach JK, Rosen CB, Haddock MG, Alberts SR, Kremers WK, Gores GJ, Nagorney DM. Liver transplantation with neoadjuvant chemoradiation is more effective than resection for hilar cholangiocarcinoma. Ann Surg. 2005 Sep;242(3):451-8; discussion 458-61. doi: 10.1097/01.sla.0000179678.13285.fa.

    PMID: 16135931RESULT

  • Darwish Murad S, Kim WR, Harnois DM, Douglas DD, Burton J, Kulik LM, Botha JF, Mezrich JD, Chapman WC, Schwartz JJ, Hong JC, Emond JC, Jeon H, Rosen CB, Gores GJ, Heimbach JK. Efficacy of neoadjuvant chemoradiation, followed by liver transplantation, for perihilar cholangiocarcinoma at 12 US centers. Gastroenterology. 2012 Jul;143(1):88-98.e3; quiz e14. doi: 10.1053/j.gastro.2012.04.008. Epub 2012 Apr 12.

    PMID: 22504095RESULT

  • Ethun CG, Lopez-Aguiar AG, Anderson DJ, Adams AB, Fields RC, Doyle MB, Chapman WC, Krasnick BA, Weber SM, Mezrich JD, Salem A, Pawlik TM, Poultsides G, Tran TB, Idrees K, Isom CA, Martin RCG, Scoggins CR, Shen P, Mogal HD, Schmidt C, Beal E, Hatzaras I, Shenoy R, Cardona K, Maithel SK. Transplantation Versus Resection for Hilar Cholangiocarcinoma: An Argument for Shifting Treatment Paradigms for Resectable Disease. Ann Surg. 2018 May;267(5):797-805. doi: 10.1097/SLA.0000000000002574.

    PMID: 29064885RESULT

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • Cristina Dopazo

    HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA

    PRINCIPAL INVESTIGATOR

  • Ramón Charco-Torra

    HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA

    PRINCIPAL INVESTIGATOR

  • Sonia Pascual-Bartolomé

    HOSPITAL GENERAL UNIVERSITARIO, ALICANTE

    STUDY CHAIR

  • Carmelo Loinaz-Segurola

    HOSPITAL UNIVERSITARIO 12 DE OCTUBRE, MADRID

    STUDY CHAIR

  • José María Álamo-Martinez

    HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO, SEVILLA

    STUDY CHAIR

  • José Luis Lucena de la Poza

    HOSPITAL UNIVERSITARIO PUERTA DE HIERRO, MAJADAHONDA

    STUDY CHAIR

  • Arturo Colon-Rodríguez

    HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON, MADRID

    STUDY CHAIR

  • Diego López-Segarra

    COMPLEJO HOSPITALARIO UNIVERSITARIO, BADAJOZ

    STUDY CHAIR

  • Yilliam Fundora-Suárez

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Andrea Bosca-Robledo

    Hospital Universitario La Fe

    STUDY CHAIR

  • Juan Andrés Echeverri-Cifuentes

    HOSPITAL UNIVERSITARIO MARQUES DE VALDECILLA, SANTANDER

    STUDY CHAIR

  • Marina Vila-Tura

    HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA

    STUDY CHAIR

  • Xavier Merino-Casabiel

    HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA

    STUDY CHAIR

  • David Leiva-Pedraza

    HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA

    STUDY CHAIR

  • María Teresa Salcedo-Allende

    HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA

    STUDY CHAIR

  • José Antonio Gracia Solanas

    HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA, ZARAGOZA

    STUDY CHAIR

  • Manuel Angel Barrera-Gómez

    HOSPITAL UNIVERSITARIO NUESTRA SEÑORA DE LA CANDELARIA, TENERIFE

    STUDY CHAIR

  • Ricardo Robles-Campos

    Hospital Universitario Virgen de la Arrixaca

    STUDY CHAIR

  • Laura Lladó-Garrida

    HOSPITAL UNIVERSITARIO DE BELLVITGE, BARCELONA

    STUDY DIRECTOR

  • María Teresa Macarulla-Mercadé

    HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA

    STUDY DIRECTOR

  • Begoña Navalpotro-Yagüe

    HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA

    STUDY DIRECTOR

  • Florian Castet

    HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA DE BARCELONA

    STUDY CHAIR

  • Julio Santoyo

    HOSPITAL REGIONAL UNIVERSITARIO DE MALAGA

    STUDY CHAIR

  • Manuel Durán Martínez

    HOSPITAL UNIVERSITARIO REINA SOFIA DE CÓRDOBA

    STUDY CHAIR

  • Natalia Zambudio

    Hospital Virgen de las Nieves (Granada)

    STUDY CHAIR

Central Study Contacts

CRISTINA DOPAZO, MD/PhD

CONTACT

+34932746113cristina.dopazo@vallhebron.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

April 24, 2020

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)