bile duct cancer Intrahepatic cholangiocarcinoma
Conditions
Interventions
During the resection of iCCA, there will be a subcutaneous chemopump implanted.
By means of this chemopump, a chemotherapeutical agent called Floxuridin will
be administered to the liver tumour thro
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years. - ECOG 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 as assessed by the following laboratory requirements to be conducted within 30 days prior to inclusion: + Absolute neutrophil count (ANC) >= 1.5 x 109/L + White blood cell count (WBC) >= 2.5 x 109/L + Platelets >= 100 x 109/L + Glomerular filtration rate (GFR) >= 30 ml/min + Haemoglobin (Hb) >= 5.5 mmol/L + Total bilirubin
Exclusion criteria
Exclusion criteria: - Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (=10 mg/day methylprednisolone equivalent excluding inhaled steroids). - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main trial endpoint is the rate of recurrence of iCCA in the liver after two years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be: complications after the surgery to remove the iCCA, complications from the chemotherapy (FUDR), the rate of recurrence of the cancer in general, quality of life, cost-effectiveness of HAIP chemotherapy, and biomarkers in the blood to predict effectivity of HAIP chemotherapy. | — |
Countries
Netherlands
Outcome results
None listed