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.
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.
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.
Single group
Hepatic Arterial Infusion Pump chemotherapy with floxuridin
Combination productParticipants 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)
Two-year hepatic recurrence free survival (hRFS)
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.
Overall recurrence free survival (RFS)
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.
Overall survival (OS)
OS is defined as the interval between pump implantation and the date of death (by any cause) or date of last follow-up
Post-operative complications
All complications rated Clavien-Dindo grade 3 or higher are recorded for the first 90 days after surgery.
Chemotherapy related adverse events (AEs)
Chemotherapy related adverse events (AEs) will be collected if they are grade III or higher according to CTCAE version 5.0
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Erasmus Medical Center
Lead sponsor
Koningin Wilhelmina Fonds
Collaborator
