SYS-CAPLIOX (AV-LIVPIBII-01)

Liver Cancer

Phase Ib/II Study of Intra-Arterial Liver Isolation Chemotherapy in Patients with Hepatic Metastases from Colorectal Cancer

Once enrolled, patients will have baseline scans and will have the AVAS device implanted. The patient will be admitted to hospital up to twice a week to be treated with the liver directed therapy until they have received 5-7 treatments of oxaliplatin, after which the device will be explanted. Oxaliplatin is approved in Australia as chemotherapy treatment for liver metastases from colorectal cancer (via IV infusion), but has not previously been approved when delivered to through the arteries to the liver using the AVAS study device. All patients will also receive Capecitabine from enrolment to 4 weeks after the AVAS explantation as a form of systemic disease management. The patient’s tumour will be scanned 4 weeks after explant of the device, and the patient will be followed up for two years. An additional CT scan will take place 8 weeks after the AVAS explantation which will be used to determine progression free survival for each patient cohort.
The treatment proposed in this study is based on the hypothesis that direct arterial infusion of chemotherapy to metastatic tumours of the liver whilst the blood flow to the organ is isolated could potentially yield benefits that cannot be achieved with existing treatment regimens.

• You may be eligible for this study if you are aged over 18 years, have hepatic metastases from histologically proven adenocarcinoma of the colon/rectum, and have had some systemic chemotherapy.
• Males or females, aged 18 years or older, with hepatic metastases from histologically proven adenocarcinoma of the colon/rectum
• Limited extrahepatic metastases in the lung or lymph nodes
• Confirmed non-progressive disease in the liver, per RECIST v1.1, halfway into the first-line systemic chemotherapy regimen after a minimum of 4 cycles of FOLFOX/XELOX ± monoclonal antibodies OR liver-dominant pre-treated or refractory patients
• Genotype: RAS mutant for first line patients only. All genetic mutations allowable for pre-treated or refractory patients
• Prior treatment with monoclonal antibody treatment is ‘greater than or equal to’ 4 weeks before implantation
• Considered medically fit for repeated general anaesthesia
• ECOG performance status 0-1
• Adequate bone marrow function (within 14 days of enrolment):
  • Haemoglobin greater than or equal to 100 g/L
  • ANC greater than or equal to 1.5 × 10^9/L
  • Platelet Count greater than or equal to 100 × 10^9/L
    • Adequate renal function (within 14 days of enrolment):
      • Serum Creatinine less than or equal to 1.5 × Upper Limit of Normal
    • Adequate liver function (within 14 days of enrolment):
      • Bilirubin less than or equal to 2.0 × Upper Limit of Normal
      • AST less than or equal to 5 × Upper Limit of Normal
    • Normal coagulation (within 14 days of enrolment):
      • INR less than or equal to
        • Able to understand the risks and benefits of the study and provide signed, written informed consent to participate
        • Willing and able to comply with all study requirements and assessments;

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