Combined Proton Therapy and Liver Transplant for Hilar Cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This program evaluates the use of proton beam therapy in combination with neoadjuvant chemotherapy and liver transplantation for hilar cholangiocarcinoma. It is not randomized; all eligible patients in the UK who meet criteria are offered PBT and subsequent treatment if appropriate. The study leverages expert MDT selection and multi-center collaboration to identify patients who may benefit from liver transplantation after neoadjuvant therapy. Outcomes of interest include feasibility, safety, and disease control within the context of a commissioned UK service evaluation. The approach builds on historical Mayo Clinic and Nebraska experiences with neoadjuvant therapy and transplantation for this disease.

Why it matters

Who can join: the full rules

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

Where it's running

• University College London Hospitals NHS Foundation Trust
  London, United Kingdom Recruiting
• The Christie NHS Foundation Trust
  Manchester, United Kingdom Recruiting

Study contacts

• Principal investigator: Maria Hawkins — University College, London
• Study coordinator: Romelie Rieu
• Email: romelie.rieu@nhs.net
• Phone: 0044 1619187172

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.