ABC-07 Trial Secures funding for Phase II
11 March 2019
A CTC study investigating the treatment of biliary tract cancer has received funding for its second phase. ABC-07, supported by Cancer Research UK, is looking to treat cancer patients with a special kind of radiotherapy in addition to the chemotherapy which they would normally receive. 

The biliary system (which includes the gall bladder, bile ducts, and surrounding structures) is responsible for transporting bile from the liver, something which aids in digestion and helps to eliminate waste. 

Biliary tract cancers are uncommon, accounting for 3% of all gastro-intestinal cancers globally. Approximately 21% of patients survive one year after diagnosis, and only 4% survive five years (1). Surgery is the sole option which could potentially cure patients with biliary tract cancer; however, most of those diagnosed have an advanced form of the disease which cannot be operated on.

ABC-07 makes use of technical advances in radiotherapy, which in recent years have permitted the safe delivery of high dose radiation to a specific target whilst reducing the risk to normal, surrounding tissue. There is currently no standard for therapy which targets the disease in this way, despite the cancer most commonly tending to relapse in and around the biliary tract (2).

This radiotherapy (known as SBRT -- stereotactic body radiotherapy) will be given to ABC-07 patients in addition to the chemotherapy drugs gemcitabine and cisplatin, which were established as the standard of care by the previous CTC-led ABC-01 and ABC-02 studies.

Having confirmed that doing so was feasible after a preliminary stage of the trial, the study has now been awarded funding to continue recruiting patients across centres nationwide. Following the early closure of a similar study in the USA, ABC-07 is currently the only trial in the world looking at SBRT treatment for biliary tract cancer patients.

Chief Investigator for the study, Professor Maria Hawkins from Oxford University Hospital (pictured), remarked: ‘I am delighted that CRUK are funding the ABC07 phase II study. I thank the team at the CTC, all site investigators, the patients and representatives for their help and continued support with ABC-07. 

‘We will continue to work to complete this study, currently the only international study addressing the important question of whether SBRT can improve outcomes for these patients with inoperable and advanced cancer in the biliary tract.’

Recruitment will now continue at 17 NHS sites across the UK, with 4 more sites due to open. 36 patients have been recruited to date, with a target to recruit 81 patients in total by end of 2021. For more information, please see the trial’s page on the CTC website.


References:
  • 1. Coupland, V.H., et al., Incidence and survival for hepatic, pancreatic and biliary cancers in England between 1998 and 2007. Cancer Epidemiol, 2012. 36(4): p. e207-14.
  • 2. Jarnagin, W.R., et al., Patterns of initial disease recurrence after resection of gallbladder carcinoma and hilar cholangiocarcinoma: implications for adjuvant therapeutic strategies. Cancer, 2003. 98(8): p. 1689-700.  


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