Study of Intra-Arterial Oxaliplatin Plus Capecitabine to Treat Liver Metastases From Colorectal Cancer

Inclusion Criteria:

1. Males or females, aged 18 years or older, with hepatic metastases from histologically proven adenocarcinoma of the colon/rectum;
2. Limited extrahepatic metastases in the lung or lymph nodes;
3. 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;
4. Genotype: RAS mutant for first line patients only. All genetic mutations allowable for pre-treated or refractory patients;
5. Prior treatment with monoclonal antibody treatment is ≥ 4 weeks before implantation;
6. Considered medically fit for repeated general anaesthesia;
7. ECOG performance status 0-1;
8. Adequate bone marrow function (within 14 days of enrolment):

   Haemoglobin ≥ 100 g/L; ANC ≥ 1.5 × 10\^9/L; Platelet Count ≥ 100 × 10\^9/L;
9. Adequate renal function (within 14 days of enrolment):

   Serum Creatinine ≤ 1.5 × Upper Limit of Normal;
10. Adequate liver function (within 14 days of enrolment):

    Bilirubin ≤2.0 × Upper Limit of Normal; AST ≤ 5 × Upper Limit of Normal;
11. Normal coagulation (within 14 days of enrolment):

    INR ≤ 1.5;
12. Able to understand the risks and benefits of the study and provide signed, written informed consent to participate;
13. Willing and able to comply with all study requirements and assessments;

Exclusion Criteria:

1. CT-angiogram confirms unsuitable vascular anatomy;
2. No measurable liver disease per RECIST v1.1;
3. Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or main portal venous thrombosis;
4. Allergies to contrast agents;
5. Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin;
6. Previous allergies associated with 5-FU or oxaliplatin;
7. Grade \> 2 peripheral neuropathy (CTCAE 5.0);
8. Significant co-morbidities;
9. Life expectancy ≤ 3 months;
10. Pregnant or breastfeeding women, or women of childbearing potential and men who are not on a reliable form of birth control or barrier method of contraception;
11. Enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study;
12. Medical conditions that preclude the testing required by the protocol, or limit study participation;