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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Hospital Vall d'Hebron Academic / other |
| Drugs / interventions | chemotherapy, durvalumab |
| Locations | 1 site (Barcelona, Barcelona) |
| Status | Recruiting |
| Started | April 24, 2020 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | May 26, 2026 |
| Trial ID | NCT04378023 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
- Study coordinator: CRISTINA DOPAZO, MD/PhD
- Email: cristina.dopazo@vallhebron.cat
- Phone: +34932746113
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.