Direct Isolation Chemotherapy to Supplement Systemic Intravenous Chemotherapy for those with Liver Metastases from Colorectal Cancer

Phase 1

Recruiting

• Conditions: iver Cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Liver Cancer; Cancer - Liver; Cancer - Bowel - Anal

• Registration Number: ACTRN12617001268336
• Lead Sponsor: AllVascular Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-01
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Males or females, aged 18 years or older, with hepatic metastases from histologically proven adenocarcinoma of the colon/rectum;
2. Limited extrahepatic metastases in the lung or lymph nodes;
3. Confirmed non-progressive disease in the liver, per RECIST v1.1, halfway into the first-line systemic chemotherapy regimen after a minimum of 4 cycles of FOLFOX/XELOX ± monoclonal antibodies OR liver-dominant pre-treated or refractory patients;
4. Genotype: RAS mutant for first line patients only. All genetic mutations allowable for pre-treated or refractory patients;
5. Prior treatment with monoclonal antibody treatment is 'greater than or equal to' 4 weeks before implantation;
6. Considered medically fit for repeated general anaesthesia;
7. ECOG performance status 0-1;
8. Adequate bone marrow function (within 14 days of enrolment):
• Haemoglobin greater than or equal to 100 g/L;
• ANC greater than or equal to 1.5 × 10^9/L;
• Platelet Count greater than or equal to 100 × 10^9/L;
9. Adequate renal function (within 14 days of enrolment):
• Serum Creatinine less than or equal to 1.5 × Upper Limit of Normal;
10. Adequate liver function (within 14 days of enrolment):
• Bilirubin less than or equal to 2.0 × Upper Limit of Normal;
• AST less than or equal to 5 × Upper Limit of Normal;
11. Normal coagulation (within 14 days of enrolment):
• INR less than or equal to 1.5
12. Able to understand the risks and benefits of the study and provide signed, written informed consent to participate;
13. Willing and able to comply with all study requirements and assessments;

Exclusion Criteria

1. CT-angiogram confirms unsuitable vascular anatomy;
2. No measurable liver disease per RECIST v1.1;
3. Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or main portal venous thrombosis;
4. Allergies to contrast agents;
5. Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin;
6. Previous allergies associated with 5-FU or oxaliplatin;
7. Grade > 2 peripheral neuropathy (CTCAE 5.0)
8. Significant co-morbidities;
9. Life expectancy less than or equal to 3 months;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate of tumours in liver as assessed via CT scans (RECIST criteria)[4 weeks after explantation of the AVAS]