Personalized Medicine for Advanced Biliary Cancer Patients

The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment. The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.

NCT Number	NCT05615818
Lead Sponsor	UNICANCER Collaborators: Cancer Research UK & UCL Cancer Trials Centre, Belgian Group of Digestive Oncology, National Cancer Institute, France, Cancer Research UK, Taiho Oncology, Inc., Servier, Zymeworks BC Inc., Accord Healthcare, Inc., Pierre Fabre Medicament
Conditions	Biliary Tract Neoplasms
Enrollment	800 participants
Start Date	2024-07-18
Primary Completion	2027-06 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-05-19