Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
Recruiting
Observational Study
Perihilar CholangiocarcinomaKlatskin Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Study type
Observational
Participants needed
8 (estimated)
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Other
Who this trial is looking for
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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).
Trial Locations
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Eligibility Criteria
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 …
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
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