Frontlight ResearchEarly access
Not yet taking people in NetherlandsPhase 1/2
Oxaliplatin given into the liver artery versus into a vein for liver cancers
Compares oxaliplatin given into the liver artery or a vein in liver tumors.
Key facts
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Where
- Rotterdam, NetherlandsSee the 2 sites
- Trial code
- Registry title
- Hepatic arterial infusion versus intravenous oxaliplatin in a safety, feasibility, and pharmacokinetic study of liver-dominant malignancies – ARTEMIS OXYS-I trial
- Status
- Not yet recruiting
- Phase
- Phase 1/2
- People taking part
- 13 people, planned
- Started
- 1 Oct 2026
- Expected to end
- 1 Oct 2028
- Type of study
- Interventional
- Record updated
- 7 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cancer in the liver: either bile duct cancer inside the liver or bowel cancer that has spread to the liver.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Intrahepatic cholangiocarcinoma (iCCA), or colorectal adenocarcinoma with liver metastases (CRLM), confirmed by tissue examination. The person must be fairly active (ECOG 0–1).
- Earlier treatment
- A working hepatic artery infusion pump must be in place, or the person can have percutaneous hepatic arterial infusion procedures, as decided by the interventional radiologist. Prior oxaliplatin chemotherapy that caused toxicity making more oxaliplatin unsafe rules a person out.
- Biomarker or test result
- Blood counts, kidney function and bilirubin must be adequate: ANC ≥ 1.5 × 10⁹/L, WBC ≥ 2.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, eGFR ≥ 30 ml/min, Hb ≥ 5.5 mmol/L, total bilirubin ≤ 25 µmol/L. Known homozygous DPYD variant carriers cannot join.
Main reasons for not taking part
- Cancer spread outside the liver (small or limited non-dominant findings are allowed)
- Known cirrhosis or significant liver disease
- Organ transplant needing immunosuppressive therapy, or steroids above 10 mg/day prednisone equivalent
- Active uncontrolled infection, including cholangitis, or unresolved bile duct blockage
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Netherlands
- Erasmus MCRotterdam, NetherlandsNot yet recruiting
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsNot yet recruiting
About the trial
What the trial wants to find out
To determine the (dose-corrected) difference in intra-tumoral concentrations of total platinum following administration of HAI oxaliplatin versus IV oxaliplatin
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Hepatic arterial infusion versus intravenous oxaliplatin in a safety, feasibility, and pharmacokinetic study of liver-dominant malignancies – ARTEMIS OXYS-I trial
- Plain-language title
- Oxaliplatin given into the liver artery versus into a vein for liver cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 7 October 2026