Study of Intra-Arterial Oxaliplatin Plus Capecitabine to Treat Liver Metastases From Colorectal C… (NCT04701281) | Clinical Trial Compass
TerminatedPhase 1/2
Study of Intra-Arterial Oxaliplatin Plus Capecitabine to Treat Liver Metastases From Colorectal Cancer
Stopped: Funding depleted to continue study
Australia5 participantsStarted 2022-03-02
Plain-language 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 catheters through a vascular access system called the AVAS. The objective of this study is to evaluate the tumour response of repeated and isolated intra-arterial liver isolation oxaliplatin compared with the standard systemic chemotherapy (intravenous 5-FU + leucovorin + oxaliplatin \[FOLFOX\] or oral capecitabine with IV oxaliplatin \[XELOX\]).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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):