NCT04378023

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

Recruiting now Last updated 9 September 2025

What this trial tests

trial testing Neoadjuvant Chemo-radiotherapy in Unresectable Cholangiocarcinoma in 34 participants. Currently enrolling.

Timeline

24 April 2020

Primary endpoint
1 June 2027

1 June 2027

Quick facts

Lead sponsor	Hospital Vall d'Hebron
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	34
Start date	24 April 2020
Primary completion	1 June 2027
Estimated completion	1 June 2027
Sites	1 location across Spain

Drugs / interventions tested

• Neoadjuvant Chemo-radiotherapy — full drug profile →
• Liver Transplantation

Conditions studied

• Unresectable Cholangiocarcinoma — all drugs for Unresectable Cholangiocarcinoma →

Sponsor

Hospital Vall d'Hebron

Who can join

Adults 18 to 70, any sex, with Unresectable Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Evolving Role of Radiation Therapy in the Treatment of Biliary Tract Cancer.
   Gkika E, Hawkins MA, Grosu AL, Brunner TB. · · 2020 · cited 26× · PMID 33381458 · DOI 10.3389/fonc.2020.604387
2. Progress in Radiotherapy for Cholangiocarcinoma.
   Wang N, Huang A, Kuang B, Xiao Y, et al · · 2022 · cited 23× · PMID 35515132 · DOI 10.3389/fonc.2022.868034
3. Current Perspectives on the Surgical Management of Perihilar Cholangiocarcinoma.
   Hewitt DB, Brown ZJ, Pawlik TM. · · 2022 · cited 19× · PMID 35565335 · DOI 10.3390/cancers14092208
4. Transplant oncology - Current indications and strategies to advance the field.
   Krendl FJ, Bellotti R, Sapisochin G, Schaefer B, et al · · 2024 · cited 15× · PMID 38304238 · DOI 10.1016/j.jhepr.2023.100965
5. Cholangiocarcinoma: The Current Status of Surgical Options including Liver Transplantation.
   Esmail A, Badheeb M, Alnahar B, Almiqlash B, et al · · 2024 · cited 11× · PMID 38893067 · DOI 10.3390/cancers16111946
6. Liver Transplant Oncology: Towards Dynamic Tumor-Biology-Oriented Patient Selection.
   Ilmer M, Guba MO. · · 2022 · cited 9× · PMID 35681642 · DOI 10.3390/cancers14112662
7. Perioperative and palliative systemic treatments for biliary tract cancer.
   Taghizadeh H, Dong Y, Gruenberger T, Prager GW. · · 2024 · cited 4× · PMID 38559612 · DOI 10.1177/17588359241230756
8. Updates and Expert Opinions on Liver Transplantation for Gastrointestinal Malignancies.
   Shannon AH, Ruff SM, Schenk AD, Washburn K, et al · · 2023 · cited 2× · PMID 37512101 · DOI 10.3390/medicina59071290