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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Simon
Gollins
-
simon.gollins@nhs.net
Mr
Jaike
Belgrave
+44 113 343 1486
artemis@leeds.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Locally advanced rectal cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Unequivocal distant metastatic disease2. Previous pelvic radiotherapy3. MRI defined predominantly mucinous tumour i.e. more than one third of tumour volume assessed to consist of mucin4. Biopsy-proven neuroendocrine tumour5. Definite MRI pelvic side wall lymph node involvement, invasion of adjacent organ, ischio-rectal fossa involvement6. Pre-existing faecal incontinence for solid stool or chronic diarrhoea (> grade 1 according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE))7. Defunctioning colostomy or ileostomy8. Prior antineoplastic therapy for rectal cancer9. Pregnant or breast feeding or of child bearing potential and unwilling to use effective contraceptive methods10. On-treatment participation in an interventional clinical study 30 days prior to randomisation11. Other concomitant antineoplastic therapy12. Inability to comply with taking oral capecitabine/AN0025 medication13. Active, uncontrolled infections14. Active, disseminated coagulation disorder15. Clinically significant cardiovascular disease ≤ 6 months before randomisation16. Prior invasive malignancy unless disease free >3 years (excluding basal cell carcinoma of the skin or carcinoma in situ)17. Known allergic reactions to either oxaliplatin or AN0025 or both capecitabine and 5-FU18. On medication with inhibitors of DPD19. Psychosocial issues which may affect treatment compliance20. Prolongation of corrected QT (QTc) interval to >480 msec when electrolyte balance is normal21. Recent occurrence (within 3 months prior to randomisation) of a major thromboembolic event, such as pulmonary embolism or proximal deep vein thrombosis, unless stable on (>14 days) therapeutic anticoagulation (aspirin ≤325 mg daily or low-molecular-weight heparin (LMWH). Subjects with a history of clinically non-significant thromboembolic events, not requiring anticoagulation, are allowed on study22. Subjects receiving oral warfarin are not eligible for this study (unless warfarin is discontinued at least 7 days prior to commencement of treatment and for the duration of the study, or oral warfarin is converted to LMWH, where local clinical opinion considers this an acceptable option)23. Other systemic and local antitumor therapies such as chemotherapy, anti-tumour immunotherapy, radiotherapy or surgical interventions that may interfere / interact with the proposed treatment as part of the ARTEMIS trial24. Other investigational drugs.
25. The following are prohibited during AN0025 therapy and therefore render patients ineligible for randomisation unless these can be switched to alternative medication prior to trial drug dosing:25.1. Non-steroidal anti-inflammatory drugs (NSAIDs)25.2. Aspirin at doses of higher than 325 mg daily25.3. Angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs)25.4. Uridine’5 diphospho-glucuronosyl transferase (UGT) inducers or inhibitors (atazanavir, probenecid, valproic acid, mefenamic acid, quinidine)25.5. Anticoagulation with anti Xa agents (i.e.:Novel oral anticoagulants (NOACs): apixaban, rivaroxaban): Low Molecular Weight Heparin (LMWH) is the preferred form of initial anticoagulation. However, if, in the assessment of the investigator, changing to a NOAC is considered appropriate, then this is acceptable assuming the thrombotic event is medically controlled.26. We recommend that patients DO NOT receive concomitant capecitabine and warfarin as the disturbance in warfarin metabolism during capecitabine treatment is unpredictable and difficult to manage. Wherever possible we would recommend either treating the patient with low molecular weight heparin instead of warfarin, or changing the patient to OxMdG treatment rather than CAPOX. If the Local Investigator feels there is no alternative to giving capecitabine and warfarin concurrently then these patients MUST have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly.Unless: A patient, in the assessment of the investigator, requires the use of prohibited anti-Xa anticoagulants for clinical management and are unable to find alternative treatments, they may be allowed to participate in the trial if the following are met: The patient has been receiving anticoagulant treatment for venous thromboembolism continuously for at least 1 month and has, in the opinion of the investigator, achieved stable response in keeping with the community standards of medical care27. Leeds CTRU is notified prior to screening/consent of the patient’s requirement for anticoagulants and received approval by Leeds CTRU.
Added 19/05/2025:28. Known complete DPD deficiency29. Known deficient mismatch repair (dMMR)/microsatellite instability high (MSI-H)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Simon
Gollins
-
simon.gollins@nhs.net
Mr
Jaike
Belgrave
+44 113 343 1486
artemis@leeds.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Leeds and funded by Adlai Nortye.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 58458
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
