NCT04195503Enrolling by invitation
Liver Transplant for Stable, Advanced Intrahepatic Cholangiocarcinoma
Liver Transplantation in Locally- Advanced, Unresectable, Non-Metastatic Intrahepatic Cholangiocarcinoma Treated With Neoadjuvant Systemic Therapy: A Single-centre, Pilot Study
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 9 Dec 2019
- Start date
- 10 Dec 2019
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04195503
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 10 Dec 2019 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Prior history of solid organ or bone marrow transplantation
Other illness
- Known history of human immunodeficiency virus (HIV) infection.
- 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
Lab values
- Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
Other
- Pregnant or breast-feeding patients (unless willing to abstain from breast-feeding)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.