Floxuridin for Intrahepatic cholangiocarcinoma

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- ECOG performance status 0 or 1\n- Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.\n- Patient is able to undergo a laparotomy\n- 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.\n- Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 30 days prior to inclusion: o\tAbsolute neutrophil count (ANC)\t≥ 1.5 x 109/L o\tWhite blood cell count (WBC) \t\t≥ 2.5 x 109/L o\tPlatelets \t\t\t\t≥ 100 x 109/L o\tGlomerular filtration rate (GFR)\t\t≥ 30 ml/min o\tHaemoglobin (Hb) \t\t\t≥ 5.5 mmol/L o\tTotal bilirubin \t\t\t\t≤ 25 µmol/L\n- Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations"}

Exclusion criteria

• {"criterion_text":"- 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 characterise or biopsy are eligible.\n- Organ allografts requiring immunosuppressive therapy.\n- Serious infections (uncontrolled or requiring treatment).\n- Participation in another interventional study for iCCA with survival as outcome.\n- Participation in another prospective study with an interventional medical product.\n- 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.\n- 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.\n- Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency.\n- Prior hepatic radiation, ablation, or resection for iCCA\n- Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.\n- (Partial) portal vein thrombosis in future liver remnant.\n- Pregnant or lactating women.\n- History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy\n- 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."}

Primary endpoints

• {"endpoint_text":"- Two-year hepatic recurrence free survival (hRFS)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Overall recurrence free survival (RFS)\n- Overall survival (OS)\n- Postoperative complications\n- Chemotherapy related adverse events (AEs)\n- Proportion of patients that started with adjuvant HAIP chemotherapy\n- Quality of life\n- Cost-effectiveness\n- Predictive biomarkers for the efficacy of HAIP chemotherapy","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

09-07-2024

Latest Decision Or Authorization Date

09-05-2025

Processing Time Days

304

Number Of Sites

4

Number Of Participants

40

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands