Liver Transplantation in Intrahepatic Cholangiocarcinoma

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06140134
Status
Recruiting
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Conditions

  • Cholangiocarcinoma, Intrahepatic
  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Liver Transplant — PROCEDURE
    Whole liver allotransplantation will be performed for patients on the liver transplant waiting list

Study Details

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.

Key Dates

Start date
Dec 15, 2023
Status verified
Mar 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Intrahepatic cholangiocarcinoma listed for liver transplant
    Listed patients enrolled with diagnosis of intrahepatic cholangiocarcinoma will be enrolled on an intent to treat basis with comparison between patients receiving transplant versus those who expire or are removed from the waitlist.

Primary Outcome Measure

5-year Overall Survival Rate (ORS) [ Time Frame: 5 years from the time of transplant or until death of patient, whichever came first ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers New Jersey Medical SchoolNewarkNew Jersey07103
Keri E Lunsford, MD, PhD
[email protected]
University HospitalNewarkNew Jersey07103
Keri E Lunsford, MD, PhD
[email protected]
Keri E Lunsford, MD, PhD (PRINCIPAL_INVESTIGATOR)
James V Guarrera, MD (SUB_INVESTIGATOR)
Flavio Paterno, MD (SUB_INVESTIGATOR)
Arpit Amin, MD (SUB_INVESTIGATOR)
Grace S Lee-Riddle, MD (SUB_INVESTIGATOR)

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By research site
Rutgers New Jersey Medical School· Newark, NJUniversity Hospital· Newark, NJ

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