Primary Sclerosing Cholangitis Clinical Trial
Official title:
Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante
Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be
subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.
Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent
in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of
developing this type of neoplasm. Only a minority of patients are suitable for resection
partly because of the anatomic position of the tumor (which often arises from the bile duct
bifurcation) and partly because of the frequently coexisting liver disease. In fact, CC is
currently considered a major contraindication to liver transplantation (OLT) at the majority
of centers, given a 5-year survival rate of 0%-35%.
New strategies have been developed for the treatment of this kind of cancer arising in PSC.
The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a
neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver
transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver
transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5
years survival. More convincing results come from the Mayo Clinic. An accurate selection of
patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy
and intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver
transplantation.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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