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Assessment of the Safety and Efficacy of Intra-Arterial Liver Isolation Chemotherapy Using an Implantable Vascular Access System

ABSTRACT: Interventions: SCREENING & WORK UP: The patient is screened by the trial staff and a comprehensive patient history is recorded. Baseline blood tests and a CTA scan is carried out to determine patient suitability. A baseline PET-CT scan is also performed to determine treatment lesions. A Quality of Life (QOL) Survey will be filled in by the patient at this time also. DEVICE IMPLANTATION PROCEDURE: The procedure involves the surgical implantation under general anaesthetic of a large bore temporary access port (a peripheral access sytem) in either the common femoral artery or the subclavian artery. The device is implanted by anastomosing the ePTFE graft skirt of the device onto the patient’s common femoral artery and tunnelling the tubing of the device through the patient’s subcutaneous tissue in the upper thigh/pectoralis and out through the skin. The implantation procedure can take between 1-3 hours and the patient can be discharged after recovery. CHEMOTHERAPY INFUSION PROCEDURE: During the chemotherapy infusion sessions the patient will be ventilated with positive end-expiratory pressure (PEEP) whilst under general anesthesia. Depending on the specific patient anatomy up to 4 catheters will be used to selectively cannulate and obstruct the target visceral vessels. Once the flow to the liver is isolated, a microcatheter will be used via the coeliac trunc to superselectively target a pre-determined liver lesion and subsequently deliver chemotherapy locally for 20-30 minutes. All catheters are removed after the infusion and the patient discharged after recovery. The procedure is expected to take between 60-200 minutes. Depending on the patient response, the patient will be infused 3-8 times over the 30 day course. DEVICE EXPLANTATION PROCEDURE: After the fi Primary outcome(s): To determine the feasibility of the implantable access port in its ability to facilitate the administration of chemotherapy via intra-arterial liver isolation. Outcome is assessed through evaluation of all the operative reports of the standardised chemotherapy infusion sessions carried out.[At every chemotherapy infusion session];To determine the safety and efficacy of intra-arterial liver isolation chemotherapy using the implantable vascular access system. Outcome is assessed through monitoring serious adverse events and adverse events such as significant infection, haematoma/haemorrhage, septicaemia, or significant thrombosis.[From implantation to 3 months post-explantation] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

DISEASE(S): 1. Secondary Hepatic Metastases From Colorectal Cancer,1. Secondary Hepatic Metastases From Colorectal Cancer2. Hepatocellular Carcinoma,2. Hepatocellular Carcinoma,Cancer-liver

PROVIDER: 2457709 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: The treatment proposed in this clinical investigation plan is to repeatedly administer intra-arterial chemotherapy to hepatic metastases from colorectal cancer when the blood flow to and from the liver has been isolated via balloon catheters. The objective of this study is to evaluate the tumour response, progression-free survival, morbidity and mortality of repeated and isolated intra-arterial hepatic infusion of oxaliplatin compared with the standard systemic chemotherapy (intravenous 5-FU + leucovorin + oxaliplatin [FOLFOX] or oral capecitabine with IV oxaliplatin [XELOX]). 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. There are three treatment stages; implantation of a vascular access device (known as the AVAS), intra-arterial chemotherapy infusions, and explantation of the AVAS. Implantation: the participant is admitted to hospital and the AVAS is surgically implanted under general anaesthetic. The AVAS is an implantable large bore cannula with one end that can be anastomosed directly onto a peripheral vessel and the opposite end exiting the patient’s skin. The device can be opened to access the patient’s vasculature when required and closed when the device is not in use. In accordance with the manufacturer’s Instructions-For-Use (IFU), the AVAS will be implanted in the axillary artery (i.e. the upper pectoral area) or in the common femoral artery (upper thigh) by a trained vascular surgeon. The implantation procedure takes around 2 hours. After implantation, the participant is monitored overnight. Intra- Primary outcome(s): Response rate of tumours in liver as assessed via CT scans (RECIST criteria)[4 weeks after explantation of the AVAS] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

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Assessment of the Safety and Efficacy of Intra-Arterial Liver Isolation Chemotherapy Using an Implantable Vascular Access System

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