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

21 september 2026 bijgewerkt door: Bas Groot Koerkamp, MD, PhD, Erasmus Medical Center

Herhaling van de lever voorkomen na gedeeltelijke hepatectomie voor intrahepatisch cholangiocarcinoom met behulp van adjuvante hepatische arteriële infusiepomp chemotherapie - pomp IV proef

The 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Nederland
    • South Holland
      • Rotterdam, South Holland, Nederland, 3015GD
        • Werving
        • Erasmus Medical Center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Bas Groot Koerkamp, MD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 18 years or older
  • ECOG or WHO performance status 0 or 1
  • Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.
  • Patient is able to undergo a laparotomy.
  • Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the GDA. Accessory or aberrant hepatic arteries are no contraindication for catheter placement.
  • 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
  • Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations.

Exclusion Criteria:

  • Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (≤ 1 cm) extrahepatic lesions that are too small to characterize or biopsy are eligible.
  • Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence or with a life expectancy longer than 5 years.
  • Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency
  • Prior hepatic radiation, ablation, or resection for iCCA.
  • Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.
  • (Partial) portal vein thrombosis in future liver remnant.
  • Pregnant or lactating women.
  • History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.
  • Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
  • Organ allografts requiring immunosuppressive therapy.
  • Serious infections (uncontrolled or requiring treatment).
  • Participation in another interventional study for iCCA with survival as outcome.
  • Participation in another prospective study with an interventional medical product.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy)

Surgery + chemo pump
Combinatie product: Hepatic Arterial Infusion Pump chemotherapy with floxuridin

Participants in this arm will receive in addition to standard care (surgery) a chemo pump. This pump will provide participants with 4 cycles of treatment with chemotherapy (Floxuridin), each lasting 4 weeks. Total treatment with chemotherapy will last 16 weeks (approx. 4 months)

Andere namen:
  • Haven
  • Haic met floxuridine
  • Pomp chemotherapie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Two-year hepatic recurrence free survival (hRFS)
Tijdsspanne: From pump implantation until 2 years after that surgery

The percentage of patients who do not have return of disease in the liver two years after surgery. The time frame is defined as the period between pump implantation and return of disease in the liver. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples.
From pump implantation until 2 years after that surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall recurrence free survival (RFS)
Tijdsspanne: From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)

The percentage of patients who do not have return of disease in the given time frame. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples.
From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)
Overall survival (OS)
Tijdsspanne: From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)

OS is defined as the interval between pump implantation and the date of death (by any cause) or date of last follow-up
From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)
Post-operative complications
Tijdsspanne: From pump implantation until 90 days after surgery

All complications rated Clavien-Dindo grade 3 or higher are recorded for the first 90 days after surgery.
From pump implantation until 90 days after surgery
Chemotherapy related adverse events (AEs)
Tijdsspanne: From inclusion until 4 weeks after the end of treatment with chemotherapy

Chemotherapy related adverse events (AEs) will be collected if they are grade III or higher according to CTCAE version 5.0
From inclusion until 4 weeks after the end of treatment with chemotherapy
Proportion of patients started with HAIP chemotherapy
Tijdsspanne: From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump

The number of patients that could receive at least 1 cycle of HAIP chemotherapy with floxuridin
From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump
Quality of life: EORTC QLQ-30
Tijdsspanne: From inclusion until 5 years after surgery

After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This validated instrument includes 30 items covering functional domains, symptom scales, and global health status. Scores range from 0 to 100, with higher scores on the global health and functional scales indicating better quality of life.

After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years.
From inclusion until 5 years after surgery
Quality of life: EQ-5D
Tijdsspanne: From inclusion until 5 years after surgery

After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the EuroQol 5-Dimension (EQ-5D) questionnaire, a standardized measure of health-related quality of life. The EQ-5D includes five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The resulting health state is converted into an index score ranging from 0 (equivalent to death) to 1 (perfect health), though negative scores are possible.

After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years.
From inclusion until 5 years after surgery
Cost-effectiveness
Tijdsspanne: From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome)

An assessment of the cost-effectiveness of HAIP chemotherapy for patients with iCCA will be made
From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome)
Predictive biomarkers in the blood for efficacy of HAIP chemotherapy
Tijdsspanne: From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first)

A total of five additional blood samples will be collected. These samples will be collected:

  • On the day of surgery before the incision is made.
  • During surgery (directly from the hepatic vein).
  • Before the start of HAIP chemotherapy.
  • After the last cycle of HAIP chemotherapy.
  • At one year after surgery or at recurrence
From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first)
Predictive biomarkers from liver tissue for efficacy of HAIP chemotherapy
Tijdsspanne: From resection until 25 years after (conform applicable laws)

Additionally, tumor tissue will be collected from the removed part of the liver during the surgery. These tissue samples will be stored for further research into biomarkers.
From resection until 25 years after (conform applicable laws)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Erasmus Medical Center

Medewerkers

Koningin Wilhelmina Fonds

Onderzoekers

  • Hoofdonderzoeker: Bas Groot Koerkamp, MD, PhD, Erasmus Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 november 2024

Primaire voltooiing (Geschat)

1 september 2028

Studie voltooiing (Geschat)

1 september 2033

Studieregistratiedata

Eerst ingediend

5 februari 2025

Eerst ingediend dat voldeed aan de QC-criteria

14 maart 2025

Eerst geplaatst (Werkelijk)

21 maart 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MEC-2024-0324
  • 2024-513726-33-00 (Ctis)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

The decision on sharing IPD has not been made within the trial team. Once this decision is made, we will update this part.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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