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

Not Applicable

Completed

• Conditions: 1. Secondary hepatic metastases from colorectal cancer2. Hepatocellular carcinoma; 1. Secondary hepatic metastases from colorectal cancer; 2. Hepatocellular carcinoma; Cancer - Liver

• Registration Number: ACTRN12611001273976
• Lead Sponsor: Dr Rodney Lane

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Colorectal cancer liver metastases patients:
1) Patients must be over 18 years of age
2) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate
3) Patients must be fit for anaesthesia
4) Patients must have histologically proven colorectal cancer
5) Patients have unresectable hepatic metastases
6) Patient has failed first line therapy
7) Patients' World Health Organization performance status less than or equal to 2
8) Patients have adequate bone marrow
9) Patients have adequate renal function
10) Patients have adequate liver function
11) Patients have normal coagulation

Hepatocellular carcinoma patients:
1) Patient must be over 18 years of age
2) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate
3) Patients must be fit for anaesthesia
4) Patients have a Child-Pugh score of A or B
5) Patients have failed 1st line therapy
6) Patients have adequate hematology/bone marrow
7) Patients have adequate liver function
8) Patients have normal coagulation

Exclusion Criteria

Colorectal cancer liver metastases patients:
1) World Health Organization performance status > 2
2) Patients have clinically significant ascites
3) Patients have dominant extra-hepatic disease
4) Technical inability to perform HAI
5) Patients have had previous treatment with SIR spheres
6) Patients have Grade 3 or 4 peripheral neuropathy
7) Patients have significant co-morbidities

Hepatocellular carcinoma patients:
1) Child-Pugh score of C
2) Patients have dominant extra-hepatic disease
3) Patients have had previous treatment with SIR-spheres
4) Technical inability to perform HAI
5) Patients have significant co-morbidities
6) Patients have advanced liver failure/complications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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]

Secondary Outcome Measures

Name	Time	Method
To increase the overall survival rate of patients. Assessed by survivorship through post-treatment follow ups.[Follow-ups beyond 3 month post-explantation];To increase the patient's response rate to the chemotherapy. Assessed by resectability of tumour post-treatment and changes in tumour size.[Baseline PET-CT and ultrasound of the liver and at 1 month post-explantation];To minimise the systemic side effects of chemotherapy. Assessed through blood samples during the chemotherapy infusion sessions.[During chemotherapy infusion sessions];To improve patient's overall quality of life. Determined through questionnaires.[Baseline and 1 month post-explantation]