NCT06986486 Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
| NCT ID | NCT06986486 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Perihilar Cholangiocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2030-01-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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 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