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 range18 Years – 89 Years
SexALL
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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…
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