Liver transplant hope for bile duct cancer patients
NCT ID NCT06140134
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a liver transplant can help people with a certain type of advanced bile duct cancer that hasn't spread. Participants will first receive chemotherapy to control the cancer, then undergo a liver transplant. The goal is to see if this approach helps them live longer compared to chemotherapy alone. The study involves 30 adults whose cancer has been stable or shrunk with at least 6 months of chemotherapy.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with biologically responsive locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) treated with neoadjuvant systemic chemotherapy with a radiographic disease stability or regression.
- Ages
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18 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rutgers New Jersey Medical School
RECRUITINGNewark, New Jersey, 07103, United States
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University Hospital
RECRUITINGNewark, New Jersey, 07103, United States
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