Liver Transplantation in Intrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorRutgers, The State University of New Jersey
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with biologically responsive locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) treated with neoadjuvant systemic chemotherapy with a radiographic disease stability or regression.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Liver Transplant
Procedure/SurgeryWhole liver allotransplantation will be performed for patients on the liver transplant waiting list
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intrahepatic cholangiocarcinoma listed for liver transplant1 intervention
Trial outcomes
Primary outcomes
1
5-year Overall Survival Rate (ORS)
5-year ORS is the length of time that patients diagnosed with locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) treated with neoadjuvant systemic therapy followed by liver transplant (LT) are still alive post-LT.
Time frame
5 years from the time of transplant or until death of patient, whichever came firstSecondary outcomes
1
Recurrence-free survival (RFS)
RFS is the length of time from liver transplantation (LT) to the time of disease recurrence, time of patient death, or time of study completion for patients with locally advanced non-metastatic intrahepatic cholangiocarcinoma treated with neoadjuvant systemic therapy followed by liver transplantation.
Time frame
From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years2
Intent-to-treat Overall Survival Rate (ITT ORS)
ITT ORS is the length of time that patients diagnosed with locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) treated with neoadjuvant systemic therapy and waitlisted for liver transplant for iCCA are still alive after being waitlisted for liver transplantation.
Time frame
5 years from time of waitlist or until death of patient, whichever came first3
Post-liver transplant functional assessments to identify postoperative complications, short-term morbidities, and long-term morbidities
All serious adverse events will be followed and documented, including bleeding requiring re-operation, hepatic artery or portal vein thrombosis, bile duct leak, bile duct stricture, primary non-function of the transplant liver, need for re-transplant of the liver.
Time frame
From date of emergence of a post-transplant adverse event until the date the adverse event is designated as resolved by investigator or its effect on patient's condition stabilizes, whichever came first, assessed up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov