Liver Transplantation in Intrahepatic Cholangiocarcinoma (NCT06140134) | Clinical Trial Compass
RecruitingNot Applicable
Liver Transplantation in Intrahepatic Cholangiocarcinoma
United States30 participantsStarted 2023-12-15
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 psy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
5-year Overall Survival Rate (ORS)
Timeframe: 5 years from the time of transplant or until death of patient, whichever came first
Trial details
NCT IDNCT06140134
SponsorRutgers, The State University of New Jersey