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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 8 participants in total. It began in 2025-06-01 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06986486 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Perihilar Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06986486 currently recruiting?
Yes, NCT06986486 is actively recruiting participants. Contact the research team at vincenzo.mazzaferro@istitutotumori.mi.it for enrollment information.
Where is the NCT06986486 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06986486 clinical trial?
NCT06986486 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The trial plans to enroll 8 participants.