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

Recruitingn/aAges 18 Years - 70 YearsAllHospital Vall d'Hebron
NCT04378023 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radiochemotherapy 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 all patients included in the study at 1,3 and 5 years; 3) the rate of patients included in the study who are finally transplanted.

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📋 Eligibility rules (as published)
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
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What it tests

  • Neoadjuvant Chemo-radiotherapy
  • Liver Transplantation
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Where

1 site
Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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