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Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma

RECRUITINGSponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Actively Recruiting
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Started2025-06-01
Est. completion2030-01-01
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

Summary

This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (SBRT).

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
Inclusion Criteria:

* Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:
* Transcatheter biopsy or brush cytology
* CA-19.9 \> 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography
* Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
* Age between 18 years and 70 years
* Absence of intra- and extrahepatic metastases
* Absence of lymph-nodal metastases at any site
* Biliary stenting of all liver districts
* No contraindications to liver transplantation
* No concomitant malignancies or history of other malignancies in the previous 5 years
* Written informed consent

Exclusion Criteria:

* Intrahepatic cholangiocarcinoma
* Uncontrolled infection
* Concomitant malignancies or history of other malignancies in the previous 5 years

Conditions4

CancerKlatskin TumorLiver CancerPerihilar Cholangiocarcinoma

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