Clinical trial Recruiting at 1 site Observational Ages 18 to 70

Liver transplant with chemo-radiotherapy for unresectable hilar cholangiocarcinoma

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

Run by Hospital Vall d'Hebron · NCT04378023 · Data updated 2026-11-12

This study is testing if liver transplants combined with chemotherapy and radiation can help younger patients with inoperable hilar cholangiocarcinoma live longer and stay cancer-free.

More Unresectable Intrahepatic Cholangiocarcinoma trials

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment34 (estimated)
SponsorHospital Vall d'Hebron
Academic / other
Drugs / interventionschemotherapy, durvalumab
Locations1 site (Barcelona, Barcelona)
StatusRecruiting
StartedApril 24, 2020
Main results expectedJune 1, 2027
Study endsJune 1, 2027
Registry record updatedMay 26, 2026
Trial IDNCT04378023 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients aged 70 or younger with unresectable hilar cholangiocarcinoma ≤3cm in diameter and no evidence of metastases.

Probably not a fit

Patients with prior chemotherapy or radiotherapy, metastases, or other concurrent cancers may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter study aims to evaluate the effectiveness of liver transplantation combined with neoadjuvant chemo-radiotherapy in patients diagnosed with unresectable hilar cholangiocarcinoma. Patients aged 70 or younger with tumors ≤3cm and no evidence of metastases will be included. The primary endpoint is overall survival at 1, 3, and 5 years post-transplant, while secondary endpoints include recurrence-free survival and the rate of patients who undergo transplantation. The study will involve comprehensive radiological evaluations to confirm eligibility.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates for patients with unresectable hilar cholangiocarcinoma.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with unresectable cancers through combined therapies.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
    Barcelona, Barcelona, Spain
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.