Oxaliplatin delivered straight to the liver for colorectal cancer that has spread there

Who can take part

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Previous administration of intravenous Oxaliplatin without achieving a therapeutic response, or inability to tolerate its associated adverse effects
• At least 18 years of age at the time of signing the Informed Consent Form
• Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial/Investigation treatment(s)) or commitment to a vasectomised partner. Pre-menopausal women (have had menstruation ≤12 months) must be willing to undergo hormone suppression during treatment because of anticoagulation during each Liver Isolated Therapy
• Presence of hepatic metastases from histologically proven adenocarcinoma of the colon/rectum
• Prior exposure to first- and second-line therapy, where such therapy may have included any of the following medications: 5-FU, oxaliplatin, FOLFOX, FOLFIRI, irinotecan, bevacizumab, and, when applicable, EGFR inhibitors
• Measurable liver lesions, per RECIST v1.1, with liver only or limited extrahepatic metastases. Primary tumour should have been resected
• ECOG performance status 0-1
• Considered medically fit for repeated general anaesthesia
• Inner diameter of desired peripheral artery ≥6mm

Who cannot take part

• Participant has a history of: • Allergies to contrast agents • Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin • Previous allergies associated with oxaliplatin
• Prior treatment with monoclonal bodies within 4 weeks of implantation with the AVAS
• Medical conditions that preclude the testing required by the protocol, or limit study participation
• Inadequate liver function (within 14 days of enrolment): • Bilirubin > 2.0 × Upper Limit of Normal; • AST > 5 × Upper Limit of Normal
• Normal coagulation (within 14 days of enrolment): • INR > 1.5
• Inadequate bone marrow function (within 14 days of enrolment): • Haemoglobin < 10 g/dL; • ANC < 1.5 × 109/L; • Platelet Count < 100 × 109/L
• Inadequate renal function (within 14 days of enrolment): • Serum Creatinine > 1.5 × Upper Limit of Normal
• Grade > 2 peripheral neuropathy according to CTCAE 5.0, where grade 2 is defined as moderate symptoms; limiting instrumental activities of daily living and grade 3 as severe symptoms limiting self-care activities such as eating
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
• Participation in an interventional Trial/Investigation with an investigational medicinal product (IMP) or device
• Significant co-morbidities
• Life expectancy < 3 months