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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Decision date (initial)

2026-02-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

financial grant and free delivery of AVAS device by Isovasc medical company

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Therapy, Safety

To confirm the safety, tolerability and efficacy and to evaluate the clinical practicality of the use of the AVAS device for repeated intermittent arterial access in the performance of Liver Isolated Oxaliplatin (LIOX) infusion

Secondary objectives 1

1. To collect data that might be associated with lesion-based response of the through AVAS targeted chemotherapy delivery

Conditions and MedDRA coding

colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

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

Exclusion criteria 12

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of adverse events

Secondary endpoints 1

1. Liver Disease Control Rate

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Principal investigator

Public contact point

Organisation

UZ Leuven

Contact name

Principal investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications