Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma

NCT06986486 | Recruiting

• 1 other identifier: 254-24
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Perihilar Cholangiocarcinoma; Klatskin Tumor

Keywords

liver transplantation; stereotactic body radiation therapy; downstaging

Outcome Measures

Primary Outcomes (1)

• 3-year overall survival

  To evaluate overall survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol

  3 years

Secondary Outcomes (3)

• 3-year recurrence-free survival

  3 years

• Safety and feasibility

  3 years

• Quality of life

  3 years

Study Arms (1)

Transplant

Patients with liver-limited unresectable perihilar cholangiocarcinoma with no other non-oncological contraindication to liver transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver-limited unresectable perihilar cholangiocarcinoma with no other non-oncological contraindication to liver transplantation

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori di Milano

Milan, Michigan, 20133, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and transplant specimen

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Vincenzo Mazzaferro, MD, PhD

CONTACT

0223902760; vincenzo.mazzaferro@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

IT (1)