Actively Recruiting
Preventing Liver Recurrence After Partial Hepatectomy for Intrahepatic Cholangiocarcinoma Using Adjuvant Hepatic Arterial Infusion Pump Chemotherapy - PUMP IV Trial
Led by Erasmus Medical Center · Updated on 2025-03-21
40
Participants Needed
1
Research Sites
260 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
Researchers are evaluating whether adding chemotherapy through a chemo pump directly into the liver can prevent the return of bile duct cancer within the liver after surgery. This study focuses on adults with intrahepatic bile duct cancer that can be treated by surgery. The main goals are to see if this additional chemotherapy reduces cancer recurrence in the liver within two years, improves overall survival, and affects quality of life. Participants will undergo surgery to remove the cancer, followed by implantation of a chemo pump. This pump delivers four cycles of chemotherapy with floxuridin directly to the liver, each cycle lasting four weeks, for a total chemotherapy duration of about sixteen weeks. The study period includes monitoring during and after treatment to assess outcomes. During the study, participants will be closely monitored for cancer recurrence in the liver and elsewhere, survival status, and quality of life using specific questionnaires. Researchers will also track post-operative complications and chemotherapy side effects. Biomarkers from blood and liver tissue will be collected to understand treatment effects, and cost-effectiveness will be evaluated. The study follow-up can last up to five years, with some biomarker evaluations extending up to 25 years according to regulations.
CONDITIONS
Brief 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
- Able to undergo laparotomy surgery
- Catheter placement for chemo pump is technically feasible based on CT scan
- Adequate bone marrow, liver, and kidney function within 30 days before inclusion
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- White blood cell count ≥ 2.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Glomerular filtration rate ≥ 30 ml/min
- Hemoglobin ≥ 5.5 mmol/L
- Total bilirubin ≤ 25 µmol/L
- Provided written informed consent according to regulations
You will not qualify if you...
- Presence of extrahepatic disease at first presentation (except small or unclear lesions ≤ 1 cm)
- Second primary cancer except treated non-melanoma skin cancer or other cancer treated >3 years ago without recurrence
- Known homozygous DPYD deficiency
- Prior liver radiation, ablation, or surgery for intrahepatic cholangiocarcinoma
- Clinical evidence of portal hypertension (ascites, varices, portal vein thrombosis), except some postoperative ascites
- Partial or complete portal vein thrombosis in future liver remnant
- Pregnant or breastfeeding women
- Significant psychiatric disability affecting consent or treatment compliance
- Serious systemic disorders compromising safety or study completion
- Organ transplant recipients on immunosuppressive therapy
- Serious infections requiring treatment
- Participation in other interventional studies for intrahepatic cholangiocarcinoma
- Participation in other prospective interventional medical product studies
- Psychological, familial, social, or geographic conditions that may hinder compliance with study protocol or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks including immediate recovery
Participants undergo surgery to remove the bile duct cancer inside the liver and have a chemo pump implanted for delivering chemotherapy.
Hospital stay for surgery plus follow-up visits during recovery
Duration - 16 weeks
Participants receive 4 cycles of chemotherapy via the hepatic arterial infusion pump, each cycle lasting 4 weeks.
Regular visits for chemotherapy administration and monitoring during treatment
Duration - Up to 5 years
Participants are monitored for recurrence, survival, adverse events, and quality of life after treatment ends.
Scheduled follow-up visits over several years
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
T
Thomas C Zwaan, MD
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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