Unresectable intrahepatic cholangiocarcinoma
Conditions
Interventions
Operation for placement of the infusion pump. 2 to 4 weeks later, patients with
6 consecutive cycles (4 weeks per cycle) of chemotherapy via the pump.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Age >= 18 years. • ECOG performance status 0 or 1 • Histologically confirmed diagnosis of intrahepatic cholangiocarcinoma (ICC). • Unresectable ICC confined to the liver (= 1.5 x 109/L o White blood cell count (WBC) >= 2.5 x 109/L o Platelets >= 100 x 109/L o Glomerular filtration rate (GFR) >= 50 ml/min o Haemoglobin (HB) >= 5.5 mmol/L o Total bilirubin
Exclusion criteria
Exclusion criteria: •Presence of extrahepatic disease at the time of first presentation. Patients with limited (portal) lymph node disease, patients with small (= 10 mg/day methylprednisolone equivalent excluding inhaled steroids). • Serious infections (uncontrolled or requiring treatment). • Participation in another interventional study for ICC 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 primary objective of this study is to evaluate efficacy, expressed by OS, of HAIP chemotherapy and concurrent systemic chemotherapy in patient with unresectable ICC in the Netherlands | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include postoperative complications, chemotherapy related adverse events, 2-, 3- and 5-years OS, progression free survival (PFS), response rate, conversion to resection rate, quality of life, and cost-effectiveness. The accuracy of CT angiography to detect extrahepatic perfusion will be measured. Next, we aim to identify predictive biomarkers for the efficacy of HAIP chemotherapy. In 5 patients at Erasmus MC, we aim to perform a PSMA PET-CT/MRI to measure PSMA expression in ICC tumours. | — |
Countries
Netherlands
Outcome results
None listed