Liver transplantation for patients with advanced intrahepatic cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of liver transplantation in improving overall survival for patients with locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) who have undergone neoadjuvant systemic therapy. It compares the outcomes of these patients to those who have historically received chemotherapy alone. The research focuses on patients with biologically responsive tumors, assessing the potential for transplantation as a viable treatment option where traditional surgical resection has shown limited success. The study is observational and will gather data on patient outcomes over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Rutgers New Jersey Medical School
  Newark, New Jersey, United States Recruiting
• University Hospital
  Newark, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Keri E Lunsford, MD, PhD — Rutgers University
• Study coordinator: Melissa Lugardo
• Email: lugardme@uhnj.org
• Phone: 973-972-8412

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.