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:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT06434493
Eligibility Criteria:
Inclusion Criteria:
General criteria
* Age 17 years and over
* Performance status 0 or 1 (Eastern Cooperative Oncology Group)
* Suitable for liver transplantation as determined by Multi Disciplinary Team (MDT)
* Able to tolerate neoadjuvant therapy.
* A history of primary sclerosing cholangitis (PSC) will be a necessary eligibility criterion at the start of the study. Part-way through recruitment to the study, the eligibility criteria may be broadened, allowing patients with sporadic / non-PSC unresectable cholangiocarcinoma to also be considered. The decision to do this will be taken by the Study Management Group, who will be monitor results closely, following an interim analysis after the first 10 patients. Suitability for Orthotropic Liver Transplant will continue to be confirmed in the regional Hepato Biliary cancer MDT.
Specific criteria
* Presence of a dominant hilar stricture or mass \<3cm on cross-sectional imaging
* Histologically proven cholangiocarcinoma by brush cytology or biopsy via Endoscopic Retrograde Cholangiopancreatography (ERCP) or Percutaneous Transhepatic Cholangiography (PTC)
* No metastatic disease, including to regional lymph nodes.
Exclusion Criteria:
General criteria
* Inability to consent
* Poor performance status
* Failed fitness assessment
* Extrahepatic disease at any stage of presentation, assessment and treatment
* Prior biliary resection or hilar dissection for attempted resection within the past 12 months
* Prior malignancy in the last 5 years (excluding early breast, prostate, cervix and non melanoma skin cancers)
Specific criteria
* Estimated Glomerular Filtration Rate (eGFR) \<30
* Prior radiation to the upper abdomen
* Uncontrolled infection
* Duodenal invasion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT06434493
Study Brief:
Protocol Section:
NCT06434493