RecruitingIntrahepatic CholangiocarcinomaCholangiocarcinoma, Intrahepatic
Liver Transplantation in Intrahepatic Cholangiocarcinoma
Eligible age
18–89 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Rutgers, The State University of New Jersey
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:
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
Where it's recruiting
New Jersey
Newark
Source: ClinicalTrials.gov · NCT06140134 · last updated 2026-03-20