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OncoMatch/Clinical Trials/NCT06888063

Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery

Is NCT06888063 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Hepatic Arterial Infusion Pump chemotherapy with floxuridin for intrahepatic bile duct cancer.

Phase 2RecruitingErasmus Medical CenterNCT06888063Data as of May 2026

Treatment: Hepatic Arterial Infusion Pump chemotherapy with floxuridinThe goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are: * Does addition of chemotherapy by means of a chemo pump lead to less return of disease within the liver two years after surgery? * Does addition of chemotherapy by means of a chemo pump lead to longer survival of patients? * Does addition of chemotherapy by means of a chemo pump lead to an increase in quality of life? Participants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Biomarker criteria

Excluded: DPYD homozygous deficiency

Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency

Performance status

ECOG OR WHO 0–1

Prior therapy

Cannot have received: hepatic radiation

Prior hepatic radiation for iCCA

Cannot have received: ablation

Prior ablation for iCCA

Cannot have received: resection

Prior resection for iCCA

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; White blood cell count (WBC) ≥ 2.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Haemoglobin (Hb) ≥ 5.5 mmol/L; adequate bone marrow function before inclusion (values may be max. 30 days old)

Kidney function

Glomerular filtration rate (GFR) ≥ 30 ml/min; adequate renal function before inclusion (values may be max. 30 days old)

Liver function

Total bilirubin ≤ 25 µmol/L; adequate liver function before inclusion (values may be max. 30 days old)

Adequate bone marrow, liver, and renal function before inclusion (values may be max. 30 days old) Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L White blood cell count (WBC) ≥ 2.5 x 10^9/L Platelets ≥ 100 x 10^9/L Glomerular filtration rate (GFR) ≥ 30 ml/min Haemoglobin (Hb) ≥ 5.5 mmol/L Total bilirubin ≤ 25 µmol/L

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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