2025-523261-25-00招募中2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •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 5-FU, oxaliplatin, 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
排除标准
- •Participant has a history of: • Allergies to contrast agents • Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin • Previous allergies associated with oxaliplatin
- •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
- •Medical conditions that preclude the testing required by the protocol, or limit study participation
- •Grade > 2 peripheral neuropathy according to CTCAE 5.0
- •Prior treatment with monoclonal bodies within 4 weeks of implantation with the AVAS
- •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
- •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;
结局指标
主要结局
Incidence of adverse events
Incidence of adverse events
次要结局
- Liver Disease Control Rate
研究者
Principal investigator
Scientific
UZ Leuven
研究点 (1)
Loading locations...
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