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Liver Transplantation for Intrahepatic Cholangiocarcinoma

This observational study is looking at how well liver transplantation works for people with a type of liver cancer called intrahepatic cholangiocarcinoma (iCCA). This is a cancer that starts in the bile ducts inside the liver. Researchers want to see if patients who receive a whole liver transplant live longer compared to those who historically received only chemotherapy. You might be able to join if you are between 18 and 89 years old and have been diagnosed with locally advanced iCCA that cannot be removed by surgery, and has not spread to blood vessels, lymph nodes, or other parts of the body. The main goal is to measure how many patients are still alive five years after their transplant. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will observe outcomes without assigning treatments. It plans to include 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years from the time of transplant or until death.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06140134

Liver Transplantation in Intrahepatic Cholangiocarcinoma

Recruiting
Not specifiedAges 18–89Observational
Rutgers, The State University of New Jersey
~30 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Liver Transplant

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
5-year Overall Survival Rate (ORS)
Measured over 5 years from the time of transplant or until death of patient, whichever came first

Conditions

Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma, Intrahepatic

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Intrahepatic Cholangiocarcinoma

NCT06140134

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Rutgers New Jersey Medical School

    Newark, New Jerseystudy coordinator listed

    Recruiting

  • University Hospital

    Newark, New Jerseystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Keri E Lunsford, MD, PhD · PRINCIPAL_INVESTIGATOR · Rutgers University

Who to contact

Melissa Lugardo
[email protected]
973-972-8412
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • 5-year Overall Survival Rate (ORS)5 years from the time of transplant or until death of patient, whichever came first

    5-year ORS is the length of time that patients diagnosed with locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) treated with neoadjuvant systemic therapy followed by liver transplant (LT) are still alive post-LT.