Liver Transplantation in Intrahepatic Cholangiocarcinoma

Recruiting now

Conditions studied: Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Intrahepatic

In brief

The aim of the current study is to determine the potential efficacy of liver transplantation in the form of patients' overall survival (OS) after neoadjuvant systemic therapy in patients with biologically responsive locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) in comparison to patients historically treated with chemotherapy alone.

Key facts

Study ID

NCT06140134

Run by

Rutgers, The State University of New Jersey

People needed

30

Starts

2023-12-15

Expected to finish

2029-11-01

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years of age on the day of consenting to the study.
• Patients must have histologically confirmed diagnosis of locally advanced intrahepatic cholangiocarcinoma
• Confirmed diagnosis of locally advanced unresectable iCCA with no vascular invasion, lymph node, or extrahepatic disease.
• Unresectable disease based on tumor location or underlying liver disease
• Patients must have ≥ 6 months of disease stability or tumor regression on neoadjuvant therapy. In cases in which patients had received second-line therapy, disease must also have been controlled for ≥ 6 months on that regimen.
• Patients who had previous surgical resection for iCCA are eligible if surgery occurred more than 6 months prior to listing, and patients have had ≥ 6 months of disease stability or response on therapy.
• ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A).
• Patients must have organ and marrow function acceptable for liver transplantation per institutional protocol:
• If history of chronic hepatitis B virus (HBV) infection, viral load should be undetectable on suppressive therapy.
• If history of chronic hepatitis C virus (HCV) infection, patients should have undetectable HCV viral load.
• Women of child-bearing years must have contraception plan in place from the time of study enrollment until at least one year following liver transplant.
• Ability to understand and the willingness to sign a written informed consent document
• Meets all other medical and psychosocial criteria for liver transplant
• Demonstrate ability to comply with study procedures

You may not qualify if…

• Age <18 years of age on the day of consenting to the study.
• Patients who have extrahepatic metastases, lymph node involvement, invasion or encasement of major hepatic vascular structures, perforation of the visceral peritoneum, invasion of extrahepatic structures, invasion of perihilar fat, periductular invasion, concurrent hepatoma or mixed hepatocellular cholangiocarcinoma.
• Concurrent severe and/or uncontrolled concurrent illness including, but not limited to, ongoing or active infection, acute fulminant liver failure, symptomatic congestive heart failure, unstable angina pectoris, severe uncorrected coronary artery disease, severe cerebrovascular disease, severe pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements and that would exclude the patient from eligibility for liver transplantation per institutional protocol.
• Prior solid organ or bone marrow transplant
• Dependent on ≥2 IV inotropic support to maintain hemodynamics
• Previous (within the past 5 years) or concurrent presence of other cancer, except non-melanoma skin cancer and in situ carcinomas.
• Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score >1 (Karnofsky <70%, see Appendix A).
• Unable to understand and sign a written informed consent document
• Untreated viral hepatitis
• Pregnant or breast-feeding women
• HIV-infected patients

Where it is running

• Rutgers New Jersey Medical School — Newark, New Jersey, United States (enrolling)
• University Hospital — Newark, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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