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RecruitingNCT06986486

Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma

Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

8 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

Perihilar CholangiocarcinomaKlatskin Tumor

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria11

  • 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 Criteria3

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

Locations(1)

Fondazione IRCCS Istituto Nazionale Tumori di Milano

Milan, Michigan, Italy

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NCT06986486

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