Actively Recruiting
Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery
Led by Erasmus Medical Center · Updated on 2025-03-21
40
Participants Needed
1
Research Sites
353 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
K
Koningin Wilhelmina Fonds
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- ECOG or WHO performance status 0 or 1
- Diagnosis of resectable intrahepatic cholangiocarcinoma on imaging without need for biopsy before surgery
- Patient can undergo laparotomy surgery
- Catheter placement for hepatic arterial infusion pump chemotherapy is feasible based on CT scan
- Adequate bone marrow, liver, and kidney function within 30 days before inclusion
- Absolute neutrophil count (ANC) at least 1.5 x 10^9/L
- White blood cell count (WBC) at least 2.5 x 10^9/L
- Platelet count at least 100 x 10^9/L
- Glomerular filtration rate (GFR) at least 30 ml/min
- Hemoglobin at least 5.5 mmol/L
- Total bilirubin at most 25 µmol/L
- Written informed consent given according to regulations
You will not qualify if you...
- Presence of cancer outside the liver at first presentation, except small extrahepatic lesions less than or equal to 1 cm that are too small to biopsy
- Second primary cancer except treated non-melanoma skin cancer or other cancer treated over 3 years ago without recurrence and life expectancy over 5 years
- Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency
- Prior liver radiation, ablation, or surgery for intrahepatic cholangiocarcinoma
- Clinical signs of portal hypertension such as ascites, varices, or portal vein thrombosis (some post-surgery ascites allowed)
- Partial or full portal vein thrombosis in the future liver remnant
- Pregnant or breastfeeding women
- Significant psychiatric disability preventing informed consent or compliance
- Serious systemic disorders compromising safety or study completion
- Organ transplant recipients on immunosuppressive therapy
- Serious uncontrolled infections
- Participation in another interventional study for intrahepatic cholangiocarcinoma affecting survival
- Participation in another study with an interventional medical product
- Psychological, familial, social, or geographic conditions that may prevent compliance with the study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
Research Team
B
Bas Groot Koerkamp, MD, PhD
CONTACT
T
Thomas C Zwaan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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