Hepatic arterial infusion versus intravenous oxaliplatin in a safety, feasibility, and pharmacokinetic study of liver-dominant malignancies – ARTEMIS OXYS-I trial

Condition studied

Colorectal liver metastases, Intrahepatic cholangiocarcinoma

Investigational medicinal product(s)

Every trial of Pantoprazole, Omeprazole and Capecitabine across our registers →

Eligibility

Primary endpoint

• The (dose-corrected) difference in intra-tumoral total platinum concentrations following administration of HAI oxaliplatin versus IV oxaliplatin

Endpoint detail

• Difference in intra-tumoral total platinum concentration following HAI 130 mg/m² versus HAI 85 mg/m²., • Difference in non-tumorous liver tissue total platinum concentration following IV 85 mg/m² versus HAI 85 mg/m²., • Difference in non-tumorous liver tissue total platinum concentration following HAI 130 mg/m² versus HAI 85 mg/m²., • Systemic pharmacokinetic parameters of total platinum, including plasma levels, Cmax, Tmax, Area Under the Curve (AUC), t1/2, Cl, Vd after administration of oxaliplatin via intravenous infusion versus via hepatic arterial infusion., • Incidence and grade of adverse events per treatment cycle and cumulative over the entire treatment period according to NCI CTCAE v6.0, • Post-procedural complications according to the modified CIRSE classification., • Feasibility parameters including completion rate of all planned oxaliplatin administrations and liver biopsies, technical success of HAI procedures, adherence to scheduled blood sampling, need for dose modifications or treatment delays due to safety or technical issues, and patient-reported tolerability of study procedures., • Response rate after study treatment, is measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Response rate is defined as a complete response, a partial response, or stable disease, • Progression free survival, defined as the interval between pre-treatment imaging and the earliest occurrence of disease progression, or death, whichever came first. Progression is defined based on the RECIST 1.1 criteria, or the confirmed emerge of local non-primary, metastatic, or nodal disease., • Overall survival, defined as the interval between first study treatment and date of death., • Quality of life measured with QLQ-C30 and EQ-5D