RecruitingNCT06140134

Liver Transplantation in Intrahepatic Cholangiocarcinoma

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


Sponsor

Rutgers, The State University of New Jersey

Enrollment

30 participants

Start Date

Dec 15, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating liver transplantation as a treatment option for people with intrahepatic cholangiocarcinoma (iCCA) — a type of bile duct cancer that starts inside the liver — that is locally advanced and cannot be surgically removed. Patients who have had stable disease on pre-transplant drug therapy may qualify for a transplant. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of locally advanced intrahepatic cholangiocarcinoma - Your cancer cannot be surgically removed due to its location or underlying liver disease - There is no spread to blood vessels, lymph nodes, or outside the liver - Your disease has been stable or improving for at least 6 months on drug therapy before transplant consideration **You may NOT be eligible if...** - Your cancer has spread to lymph nodes, blood vessels, or outside the liver - Your disease has not been stable for at least 6 months on neoadjuvant therapy - You have conditions that would make you ineligible for liver transplantation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELiver Transplant

Whole liver allotransplantation will be performed for patients on the liver transplant waiting list


Locations(2)

Rutgers New Jersey Medical School

Newark, New Jersey, United States

University Hospital

Newark, New Jersey, United States

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NCT06140134


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