Hepatic arterial infusion versus intravenous oxaliplatin in a safety, feasibility, and pharmacokinetic study of liver-dominant malignancies – ARTEMIS OXYS-I trial
Key facts
- Where
- Rotterdam, HollandiaSee the 2 sites
- Phase
- 1/2. fázis
Where in Hollandia
- Erasmus MCRotterdam, HollandiaToborzás még nem indult
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2026-527509-39-01
- Record updated
- 2026. október 7.
- Original description
To determine the (dose-corrected) difference in intra-tumoral concentrations of total platinum following administration of HAI oxaliplatin versus IV oxaliplatinRead full original descriptionShow less
To determine the (dose-corrected) difference in intra-tumoral concentrations of total platinum following administration of HAI oxaliplatin versus IV oxaliplatin
Inclusion: Age ≥ 18 years; ECOG performance status 0–1; Histologically confirmed diagnosis of intrahepatic cholangiocarcinoma (iCCA) or colorectal adenocarcinoma with liver metastases (CRLM); Adequate organ function prior to inclusion: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, White blood cell count (WBC) ≥ 2.5 × 10⁹/L, Platelets ≥ 100 × 10⁹/L, o Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min, Haemoglobin (Hb) ≥ 5.5 mmol/L, Total bilirubin ≤ 25 µmol/L; Written informed consent; Presence of a functioning hepatic artery infusion pump (HAIP) in situ or eligibility for percutaneous hepatic arterial infusion procedures, as determined by the treating interventional radiologist.
Exclusion: Organ transplantation requiring immunosuppressive therapy; Chronic corticosteroid use >10 mg/day (prednisone equivalent); Prior hepatic radiation, ablation, or resection outside of the PUMP protocol that interferes with HAIP treatment; Prior oxaliplatin-based chemotherapy resulting in toxicity that, in the opinion of the treating oncologist, contraindicates further oxaliplatin treatment; Any condition that, in the opinion of the investigator, would make participation not in the patient’s best interest or could limit compliance with the study protocol and follow-up schedule; Known cirrhosis or clinically significant underlying liver disease (e.g. advanced fibrosis, portal hypertension); Active uncontrolled infection, including cholangitis; Serious comorbidities or systemic disorders that may compromise patient safety or study participation; Extrahepatic metastases. Patients with small (≤1 cm) indeterminate lesions, or limited locoregional lymph node involvement considered clinically non-dominant, are eligible; Known homozygous dihydropyrimidine dehydrogenase gene (DPYD) variant carrier; Biliary obstruction not adequately resolved (i.e. persistent hyperbilirubinemia or ongoing cholangitis); Pregnancy or lactation.