Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
Cancer Research UK and Stand Up To Cancer
Chief Investigator:
Professor Maria Hawkins
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Addition of stereotactic body radiotherapy to systemic chemotherapy in locally advanced biliary tract cancers
Design: ABC-07 is a multicentre phase II trial, with a 2:1 randomisation between 6 cycles of cisplatin and gemcitabine (CisGem) chemotherapy followed by Stereotactic Body Radiotherapy (SBRT), and 8 cycles CisGem chemotherapy for patients with locally advanced biliary tract cancer (BTC). 
Treatment: All patients are registered to receive 6 cycles of chemotherapy. Patients are then randomised to receive either:

  • 5 or 15 fractions of SBRT over 5-21 days or  (number of fractions and duration of therapy depends on size of the tumour as measured on the end of cycle 4 imaging scan),
  • two further cycles of CisGem,
Patients are followed up every 3 months for up to 2 years after registration. 
Key inclusion/exclusion criteria: Patients must have locally advanced, non-resectable biliary tract carcinoma (intra- or extra- hepatic), measurable disease (RECIST v1.1) (or be visible for targeting with radiation), and tumours ≤12cm in the longest dimension. Patients are excluded if they have metastatic disease, cancer of the gall bladder, or ampulla or have had previous radiotherapy for their BTC.
Duration of recruitment: 6 years. 
The full phase II trial is preceded by a feasibility stage, the aim of which is to determine if it is feasible to deliver SBRT in a multi-centre trial setting in a rare disease.  In particular, will clinicians recruit to the trial and will sufficient numbers of patients accept randomisation. The main aim of the phase II trial is to compare the efficacy of the treatment regimens in terms of progression-free survival.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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