Actively Recruiting
Liver Transplantation in Intrahepatic Cholangiocarcinoma
Led by Rutgers, The State University of New Jersey · Updated on 2026-03-20
30
Participants Needed
2
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Liver Transplantation in Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older on the day of consenting to the study
- Histologically confirmed diagnosis of locally advanced intrahepatic cholangiocarcinoma
- Locally advanced unresectable iCCA with no vascular invasion, lymph node, or extrahepatic disease
- Unresectable disease due to tumor location or underlying liver disease
- At least 6 months of disease stability or tumor regression on neoadjuvant therapy
- Previous surgical resection allowed if surgery was more than 6 months prior and disease stable or responding
- ECOG performance status 0 or 1 (Karnofsky 70% or higher)
- Organ and marrow function suitable for liver transplantation per institutional protocol
- Undetectable viral load if history of chronic hepatitis B or C
- Women of child-bearing years must use contraception until at least one year after transplant
- Ability to understand and willingness to sign informed consent
- Meeting all other medical and psychosocial criteria for liver transplant
- Ability to comply with study procedures
You will not qualify if you...
- Age under 18 years on the day of consenting
- Presence of extrahepatic metastases, lymph node involvement, or major vascular invasion
- Perforation of visceral peritoneum or invasion of extrahepatic structures
- Concurrent hepatoma or mixed hepatocellular cholangiocarcinoma
- Severe or uncontrolled illnesses including active infection, liver failure, heart failure, unstable angina, severe coronary artery or cerebrovascular disease, severe lung disease, or psychiatric/social issues limiting compliance
- Prior solid organ or bone marrow transplant
- Dependent on two or more IV inotropic supports
- Other cancers within past 5 years except non-melanoma skin cancer or in situ carcinomas
- ECOG performance status above 1 (Karnofsky below 70%)
- Unable to understand or sign informed consent
- Untreated viral hepatitis
- Pregnant or breastfeeding women
- HIV infection
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
Actively Recruiting
2
University Hospital
Newark, New Jersey, United States, 07103
Actively Recruiting
Research Team
M
Melissa Lugardo
CONTACT
A
Angenie Preval, PA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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