2026-527509-39-01Not yet recruitingPhase 1/2
Hepatic arterial infusion versus intravenous oxaliplatin in a safety, feasibility, and pharmacokinetic study of liver-dominant malignancies – ARTEMIS OXYS-I trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 Oct 2026
Brief summary (registry, in English)
To determine the (dose-corrected) difference in intra-tumoral concentrations of total platinum following administration of HAI oxaliplatin versus IV oxaliplatin
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 23 Jul 2026
- Start date
- 1 Oct 2026
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Liver and biliary tract cancer
- EU CT number
- 2026-527509-39-01
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 13
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus MC | Rotterdam | Netherlands | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.