Status:
TERMINATED
Study of Intra-Arterial Oxaliplatin Plus Capecitabine to Treat Liver Metastases From Colorectal Cancer
Lead Sponsor:
AllVascular
Conditions:
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The treatment proposed in this trial is to administer intra-arterial chemotherapy to liver metastases from colorectal cancer when the blood flow to and from the liver has been isolated via balloon cat...
Detailed Description
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 po...
Eligibility Criteria
Inclusion
- Males or females, aged 18 years or older, with hepatic metastases from histologically proven adenocarcinoma of the colon/rectum;
- Limited extrahepatic metastases in the lung or lymph nodes;
- 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;
- Genotype: RAS mutant for first line patients only. All genetic mutations allowable for pre-treated or refractory patients;
- Prior treatment with monoclonal antibody treatment is ≥ 4 weeks before implantation;
- Considered medically fit for repeated general anaesthesia;
- ECOG performance status 0-1;
- Adequate bone marrow function (within 14 days of enrolment):
- Haemoglobin ≥ 100 g/L; ANC ≥ 1.5 × 10\^9/L; Platelet Count ≥ 100 × 10\^9/L;
- Adequate renal function (within 14 days of enrolment):
- Serum Creatinine ≤ 1.5 × Upper Limit of Normal;
- Adequate 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;
- Able to understand the risks and benefits of the study and provide signed, written informed consent to participate;
- Willing and able to comply with all study requirements and assessments;
Exclusion
- CT-angiogram confirms unsuitable vascular anatomy;
- No measurable liver disease per RECIST v1.1;
- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or main portal venous thrombosis;
- Allergies to contrast agents;
- Previous hypersensitivity or laryngo-pharyngeal dysaesthesia associated with oxaliplatin;
- Previous allergies associated with 5-FU or oxaliplatin;
- Grade \> 2 peripheral neuropathy (CTCAE 5.0);
- Significant co-morbidities;
- Life expectancy ≤ 3 months;
- Pregnant or breastfeeding women, or women of childbearing potential and men who are not on a reliable form of birth control or barrier method of contraception;
- Enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study;
- Medical conditions that preclude the testing required by the protocol, or limit study participation;
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04701281
Start Date
March 2 2022
End Date
October 19 2022
Last Update
September 18 2025
Active Locations (5)
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1
Lake Macquarie Private Hospital
Gateshead, New South Wales, Australia, 2290
2
GenesisCare, St Leonards
Saint Leonards, New South Wales, Australia, 2065
3
Sydney Adventist Hospital
Sydney, New South Wales, Australia, 2076
4
Sydney Southwest Private Hospital
Sydney, New South Wales, Australia, 2170