Oxaliplatin for Colorectal cancer

Inclusion criteria

• {"criterion_text":"- 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"}
• {"criterion_text":"- 2. At least 18 years of age at the time of signing the Informed Consent Form"}
• {"criterion_text":"- 3. 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"}
• {"criterion_text":"- 4. Presence of hepatic metastases from histologically proven adenocarcinoma of the colon/rectum"}
• {"criterion_text":"- 5. Prior exposure to 5-FU, oxaliplatin, irinotecan, bevacizumab and (when applicable) EGFR inhibitors."}
• {"criterion_text":"- 6. Measurable liver lesions, per RECIST v1.1, with liver only or limited extrahepatic metastases. Primary tumour should have been resected."}
• {"criterion_text":"- 7. ECOG performance status 0-1"}
• {"criterion_text":"- 8. Considered medically fit for repeated general anaesthesia"}
• {"criterion_text":"- 9. Inner diameter of desired peripheral artery ≥6mm"}

Exclusion criteria

• {"criterion_text":"- 1. Participant has a history of: • Allergies to contrast agents • Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin • Previous allergies associated with oxaliplatin"}
• {"criterion_text":"- 10. Inadequate liver function (within 14 days of enrolment): • Bilirubin > 2.0 × Upper Limit of Normal; • AST > 5 × Upper Limit of Normal;"}
• {"criterion_text":"- 11. Normal coagulation (within 14 days of enrolment): • INR > 1.5"}
• {"criterion_text":"- 12. Medical conditions that preclude the testing required by the protocol, or limit study participation"}
• {"criterion_text":"- 2. Grade > 2 peripheral neuropathy according to CTCAE 5.0"}
• {"criterion_text":"- 3. Prior treatment with monoclonal bodies within 4 weeks of implantation with the AVAS"}
• {"criterion_text":"- 4. 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"}
• {"criterion_text":"- 5. Participation in an interventional Trial/Investigation with an investigational medicinal product (IMP) or device"}
• {"criterion_text":"- 6. Significant co-morbidities"}
• {"criterion_text":"- 7. Life expectancy < 3 months"}
• {"criterion_text":"- 8. Inadequate bone marrow function (within 14 days of enrolment): • Haemoglobin < 10 g/dL; • ANC < 1.5 × 109/L; • Platelet Count < 100 × 109/L;"}
• {"criterion_text":"- 9. Inadequate renal function (within 14 days of enrolment): • Serum Creatinine > 1.5 × Upper Limit of Normal;"}

Primary endpoints

• {"endpoint_text":"- Incidence of adverse events","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Liver Disease Control Rate","definition_or_measurement_approach":""}

Belgium

Earliest CTIS Part Ii Submission Date

13-02-2026

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

14

Number Of Sites

1

Number Of Participants

13

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium