SAFIR ABC-10 – Precision Medicine
Research type
Research Study
Full title
Molecular targeted maintenance therapy versus standard of care in advanced biliary cancer: an international, randomised, controlled, open label, platform phase 3 trial
IRAS ID
1006649
Contact name
Daniel Couch
Contact email
Sponsor organisation
Unicancer
Clinicaltrials.gov Identifier
Research summary
The purpose of the SAFIR ABC-10 Precision Medicine trial is to assess the benefit of precision medicine compared to standard therapy for patients with advanced stage biliary tract cancer.
Biliary tract cancers have many genetic abnormalities that can be found by a thorough analysis of their biology. Some treatments called “targeted therapies” act directly on these abnormalities. Precision medicine consists of giving treatment that only attacks the cells carrying the detected abnormality.
The trial consists of two phases:
A screening phase: to identify the patients to whom the second randomised phase of the study could be offered to. A number of criteria will be verified during this period between the start of standard therapy and the 4th cycle.
A randomised phase: which consists of comparing two options: either continuing the initial standard therapy, or starting targeted treatment. This phase will begin around 12 weeks after the start of initial standard therapy.In total, 800 patients will be screened in the screening phase (~400 patients in the UK) and 159 patients in the randomised phase (~78 patients in the UK), which will be run in around 60 hospitals located in the UK and Europe (France and Belgium).
REC name
London - South East Research Ethics Committee
REC reference
23/LO/0773
Date of REC Opinion
23 Oct 2023
REC opinion
Further Information Favourable Opinion