Recruiting

Liver Transplantation

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06140134

Conditions

Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma, Intrahepatic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Liver Transplant

Study Details

Brief summary:

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.

Conditions

Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma, Intrahepatic

Study ID

NCT06140134

Start date

Dec 15, 2023

Status verified date

Mar, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Intrahepatic cholangiocarcinoma listed for liver transplant

Listed patients enrolled with diagnosis of intrahepatic cholangiocarcinoma will be enrolled on an intent to treat basis with comparison between patients receiving transplant versus those who expire or are removed from the waitlist.

Interventions

Liver Transplant

Whole liver allotransplantation will be performed for patients on the liver transplant waiting list

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Melissa Lugardo

973-972-8412lugardme@uhnj.org

Angenie Preval, PA

prevalan@uhnj.org

Locations

Rutgers New Jersey Medical School

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Keri E Lunsford, MD, PhD

keri.lunsford@rutgers.edu

University Hospital

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Keri E Lunsford, MD, PhD

keri.lunsford@rutgers.edu

Principal Investigator:

Keri E Lunsford, MD, PhD

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • liver transplantation
  • neoadjuvant systemic therapy
  • intrahepatic cholangiocarcinoma
  • iCCA
  • locally advanced non-metastatic iCCA
  • non-metastatic intrahepatic cholangiocarcinoma
  • liver transplant
  • unresectable intrahepatic cholangiocarcinoma
  • locally advanced intrahepatic cholangiocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-03-20.