Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT04195503
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04195503
Study Brief:
Protocol Section:
NCT04195503