RECRUITING

Liver Transplantation in Intrahepatic Cholangiocarcinoma

Conditions

Intrahepatic Cholangiocarcinoma Cholangiocarcinoma, Intrahepatic liver transplantation neoadjuvant systemic therapy iCCA locally advanced non-metastatic iCCA non-metastatic intrahepatic cholangiocarcinoma liver transplant unresectable intrahepatic cholangiocarcinoma locally advanced intrahepatic cholangiocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Single-Arm Nonrandomized Phase II Study of Liver Transplantation in Locally Advanced Unresectable Non-Metastatic Intrahepatic Cholangiocarcinoma Treated With Neoadjuvant Systemic Therapy

Quick Facts

Study Start:2023-12-15

Study Completion:2029-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06140134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Melissa Lugardo

CONTACT

973-972-8412

lugardme@uhnj.org

Angenie Preval, PA

CONTACT

prevalan@uhnj.org

Principal Investigator

Keri E Lunsford, MD, PhD

PRINCIPAL_INVESTIGATOR

Rutgers University

Study Locations (Sites)

Rutgers New Jersey Medical School

Newark, New Jersey, 07103

United States

University Hospital

Newark, New Jersey, 07103

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Keri E Lunsford, MD, PhD, PRINCIPAL_INVESTIGATOR, Rutgers University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-15

Study Completion Date2029-11

Study Record Updates

Study Start Date2023-12-15

Study Completion Date2029-11

Terms related to this study

Keywords Provided by Researchers

liver transplantation
neoadjuvant systemic therapy
intrahepatic cholangiocarcinoma
iCCA
locally advanced non-metastatic iCCA
non-metastatic intrahepatic cholangiocarcinoma
liver transplant
unresectable intrahepatic cholangiocarcinoma
locally advanced intrahepatic cholangiocarcinoma

Additional Relevant MeSH Terms

Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma, Intrahepatic