Status:
RECRUITING
Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Koningin Wilhelmina Fonds
Conditions:
Intrahepatic Bile Duct Cancer
Intrahepatic Cholangiocarcinoma (Icc)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06888063
Start Date
November 20 2024
End Date
September 1 2031
Last Update
March 21 2025
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD