A phase 2, single arm, open label, study on the safety and feasibility of Liver Isolated Oxaliplatin (LIOX) delivered via arterial access device for treatment of liver metastasis in colorectal cancer patients

Prior treatment

• 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

Other illness

• Medical conditions that preclude the testing required by the protocol, or limit study participation

Lab values

• 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;

Other

• 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

• 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