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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
View on ClinicalTrials.gov →
NCT06986486
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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Actively Recruiting
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Started2025-06-01
Est. completion2030-01-01
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06986486