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ENROLLING BY INVITATION

NCT04195503

Liver Transplant for Stable, Advanced Intrahepatic Cholangiocarcinoma

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is an increasingly common form of primary liver cancer, but patients with this diagnosis are not currently eligible for LT. This study proposes to offer LT as an option to patients with advanced, unresectable iCCA who demonstrate at least 6 months of disease stability /regression while receiving standard chemotherapy. Patients will be referred and screened for study participation if they have achieved 6 months of disease stability. They will be worked up for transplant and if eligible, will be listed. Disease must remain controlled while awaiting transplantation. After transplantation, patients will be followed for disease recurrence and overall survival, while receiving standard post-transplantation followup.

Official title: Liver Transplantation in Locally- Advanced, Unresectable, Non-Metastatic Intrahepatic Cholangiocarcinoma Treated With Neoadjuvant Systemic Therapy: A Single-centre, Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-12-10

Completion Date

2034-12-31

Last Updated

2024-10-10

Healthy Volunteers

Conditions

Cholangiocarcinoma, Intrahepatic

Interventions

PROCEDURE

Liver Transplantation

Surgical removal of liver containing tumor(s) and transplantation of new healthy liver graft

Inclusion Criteria: * Male or female, aged 18 years or older, at time of consent * Eastern Cooperative Oncology Group (ECOG) score : 0 or 1 at all times from study entry to LT * Able and willing to provide written informed consent. * Women of child-bearing potential must agree to use adequate birth control * Histologically-confirmed diagnosis of iCCa * Disease is deemed unresectable based on tumor location or underlying liver dysfunction * No vascular invasion, extra-hepatic disease, or lymph node involvement detected on imaging * Patients must have ≥ 6 months of disease stability or tumor regression on gemcitabine-based therapy. For patients who have progressed to second-line therapy, disease must also be controlled for ≥ 6 months on that regimen * At least 1 living donor has stepped forward, is blood group compatible and has completed a "Health History form" which, upon review by the Living Donor team, is deemed acceptable and demonstrates no obvious contraindications to donation. Exclusion Criteria: * Previous or concurrent cancer (some exceptions permitted) * 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 * Patients having received prior locoregional therapies or radiation to the tumor * Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min * Known history of human immunodeficiency virus (HIV) infection. * Prior history of solid organ or bone marrow transplantation * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study * Pregnant or breast-feeding patients (unless willing to abstain from breast-feeding)

Locations (1)

University Health Network

Toronto, Ontario, Canada