The ARTEMIS trial is for patients who have been diagnosed as having a cancer of the lower bowel, known as the rectum. This study will examine the benefit of adding an additional treatment alongside radiotherapy and chemotherapy with the hope of increasing the chance of curing rectal cancer without the need for surgery.

Background and study aims
Radiotherapy (RT) based treatment for patients with localised rectal cancer can result in long-term cure of the disease, enabling patients to avoid surgery to remove parts of the rectum (known as ‘organ preservation’ (OP)). Based on our own patient survey, OP is one of the main concerns of the patient population, though with current treatments available it is not an outcome that is available to most patients. Improving OP rate is an important priority of the trial. There is research showing encouraging results when immunotherapy is used in combination with RT treatment. To this end, the trial aims to test the efficacy of a new immunotherapy drug ‘AN0025’. Research has shown that it could be an effective treatment which allows patients a better quality of life (QoL). The trial aims to compare what would, effectively, be ‘standard care’ for patients and ‘standard care’ in combination with AN0025. There is evidence for the benefits of immunotherapy when treating localised rectal cancer, further research is required as: there is a lack of data relating to OP, new drugs and treatments that may increase rates of OP need to be evaluated, there is little information on health-related QoL and how patients experience treatment and more data is needed to better design methods of assigning patients to treatments that best suit them.
Who can participate?
The trial will be conducted at approximately 15-20 NHS sites in the UK and open to all adults in the patient population (140 patients, 70 patients in each arm).
What does the study involve?
Patients will undergo a regime of either LCCRT or SCRT (dependant on clinician choice) that will take 1-5 weeks, followed by 12 weeks of chemotherapy (this combination is referred to as ‘total neoadjuvant therapy’). Patients on the experimental arm will begin taking AN0025 prior to beginning their RT and will stop when their chemotherapy ends. Both arms will then be followed up at 4, 6, 9, 12, 18, 24 and 30 months (post-start of RT) where they will attend clinic and perform assessments.