Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma

NANot yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

June 1, 2028

Study Completion Date

June 1, 2029

Conditions
Cholangiocarcinoma
Interventions
RADIATION

Proton Beam Therapy

All patients to be offered neoadjuvant proton beam therapy to a dose of 45 Gray (Gy) in 15 fractions over 3 weeks, with a tumour boost to 67.5 Gray (Gy)

DRUG

Concurrent oral capecitabine chemotherapy

All patients to be offered concurrent oral capecitabine 625mg/m2 twice daily on radiation days

DRUG

Cisplatin & Gemcitabine intravenous chemotherapy

Following chemoradiotherapy (PBT + capecitabine), and whilst on the liver transplant waiting list, patients will be offered up to 6 cycles of standard chemotherapy with cisplatin and gemcitabine.

PROCEDURE

Orthotropic Liver Transplant

If still eligible after neoadjuvant treatment (PBT + capecitabine), patients will be added to the liver transplant waiting list.

All Listed Sponsors
collaborator

University College London Hospitals

OTHER

collaborator

University College, London

OTHER

collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

lead

The Christie NHS Foundation Trust

OTHER

NCT06434493 - Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma | Biotech Hunter | Biotech Hunter