Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery
NCT ID: NCT06888063
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-11-20
2031-09-30
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy)
Surgery + chemo pump
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Koningin Wilhelmina Fonds
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Bas Groot Koerkamp, MD, PhD
Principal Investigator and Professor of Pancreato-Biliary Surgery
Principal Investigators
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Bas Groot Koerkamp, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-513726-33-00
Identifier Type: CTIS
Identifier Source: secondary_id
MEC-2024-0324
Identifier Type: -
Identifier Source: org_study_id
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