Actively Recruiting

Age: 18Years - 89Years
All Genders
ID06140134

Liver Transplantation After Neoadjuvant Therapy in Locally Advanced Unresectable Non-Metastatic Intrahepatic Cholangiocarcinoma A Single-Arm Phase II Study

Led by Rutgers, The State University of New Jersey · Updated on 2026-03-20

30

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating liver transplantation as a treatment option for patients with biologically responsive locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) who have undergone neoadjuvant systemic therapy. This study aims to compare overall survival rates of these patients after liver transplantation to historical outcomes of patients treated only with chemotherapy. Intrahepatic cholangiocarcinoma is a primary liver cancer with poor survival rates following surgical resection due to high tumor recurrence. The study involves patients with locally advanced unresectable iCCA who have shown at least 6 months of disease stability or regression on neoadjuvant systemic therapy. Eligible patients are listed for liver transplantation and receive a whole liver allotransplant when a matching donor liver becomes available. This single-center phase II study tracks patients listed for transplant and compares outcomes between those who receive the transplant and those who expire or are removed from the waiting list. Participants will be closely monitored before and after transplantation, with assessment of overall survival over 5 years as the primary outcome. Secondary outcomes include recurrence-free survival, intent-to-treat overall survival, and post-transplant functional assessments to identify complications and morbidities. Follow-up includes evaluations for tumor progression, monitoring of adverse events, and compliance with study procedures, with total participation lasting up to 5 years.

CONDITIONS

Brief Title

Liver Transplantation in Intrahepatic Cholangiocarcinoma

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older on the day of consenting to the study
  • Histologically confirmed diagnosis of locally advanced intrahepatic cholangiocarcinoma
  • Locally advanced unresectable iCCA with no vascular invasion, lymph node, or extrahepatic disease
  • Unresectable disease based on tumor location or underlying liver disease
  • At least 6 months of disease stability or tumor regression on neoadjuvant therapy (including second-line therapy if applicable)
  • Previous surgical resection for iCCA allowed if surgery was more than 6 months before listing and patient has had at least 6 months of disease stability or response on therapy
  • ECOG performance status 0 or 1 (Karnofsky 70% or higher)
  • Organ and marrow function acceptable for liver transplantation per institutional protocol
  • Undetectable viral load if history of chronic hepatitis B or C on suppressive therapy
  • Women of child-bearing age must have contraception plan from enrollment until at least one year post-transplant
  • Ability to understand and willing to sign informed consent
  • Meets all other medical and psychosocial criteria for liver transplant
  • Ability to comply with study procedures
Not Eligible

You will not qualify if you...

  • Age under 18 years on the day of consenting
  • Presence of extrahepatic metastases, lymph node involvement, or invasion of major hepatic vascular structures
  • Perforation of visceral peritoneum, invasion of extrahepatic structures, perihilar fat, or periductular invasion
  • Concurrent hepatoma or mixed hepatocellular cholangiocarcinoma
  • Severe or uncontrolled illness such as active infection, acute liver failure, congestive heart failure, unstable angina, severe coronary artery disease, cerebrovascular disease, pulmonary disease, or psychiatric illness limiting study compliance
  • Prior solid organ or bone marrow transplant
  • Dependence on 2 or more IV inotropic drugs to maintain hemodynamics
  • History or current cancer within past 5 years except non-melanoma skin cancer and in situ carcinomas
  • ECOG performance status greater than 1 (Karnofsky less than 70%)
  • Unable to understand or sign informed consent
  • Untreated viral hepatitis
  • Pregnant or breastfeeding women
  • HIV infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - At least 6 months

Participants with locally advanced unresectable intrahepatic cholangiocarcinoma receive neoadjuvant systemic therapy and are monitored for at least 6 months of disease stability or regression before liver transplantation.

Regular monitoring visits as part of neoadjuvant therapy

Liver Transplant

Duration - Single day procedure with immediate post-operative care

Participants who meet transplant listing criteria undergo liver transplantation when a donor liver becomes available.

1 transplant procedure visit

Post-operative Follow-up

Duration - Up to 5 years

Participants are followed after liver transplantation to assess recovery, monitor for complications, and evaluate recurrence and survival outcomes.

Multiple follow-up visits over 5 years

Trial Site Locations

Total: 2 locations

1

Rutgers New Jersey Medical School

Newark, New Jersey, United States, 07103

Actively Recruiting

2

University Hospital

Newark, New Jersey, United States, 07103

Actively Recruiting

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Research Team

M

Melissa Lugardo

A

Angenie Preval, PA

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Expert consensus document: Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA).

Jesus M Banales, Vincenzo Cardinale, Guido Carpino...

https://pubmed.ncbi.nlm.nih.gov/27095655

Conditional Probability of Long-term Survival After Liver Resection for Intrahepatic Cholangiocarcinoma: A Multi-institutional Analysis of 535 Patients.

Gaya Spolverato, Yuhree Kim, Aslam Ejaz...

https://pubmed.ncbi.nlm.nih.gov/25831462

Recurrence Patterns and Disease-Free Survival after Resection of Intrahepatic Cholangiocarcinoma: Preoperative and Postoperative Prognostic Models.

Alexandre Doussot, Mithat Gonen, Jimme K Wiggers...

https://pubmed.ncbi.nlm.nih.gov/27296525

Orthotopic liver transplantation in combination with neoadjuvant therapy: a new paradigm in the treatment of unresectable intrahepatic cholangiocarcinoma.

Abbas Rana, Johnny C Hong

https://pubmed.ncbi.nlm.nih.gov/22333563