Preventing liver recurrence after partial hepatectomy for intrahepatic cholangiocarcinoma using adjuvant hepatic arterial infusion pump chemotherapy – PUMP IV trial
- Conditions
- Intrahepatic cholangiocarcinoma (iCCA)Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]Therapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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: oAbsolute neutrophil count (ANC)= 1.5 x 109/L oWhite blood cell count (WBC) = 2.5 x 109/L oPlatelets = 100 x 109/L oGlomerular filtration rate (GFR)= 30 ml/min oHaemoglobin (Hb) = 5.5 mmol/L oTotal bilirubin = 25 µmol/L, Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations
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., 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., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of effectiveness of adjuvant HAIP chemotherapy in patient with resectable intrahepatic CCA.;Secondary Objective: Evaluation of effectiveness, side-effects, quality of life, and cost-effectiveness.;Primary end point(s): Two-year hepatic recurrence free survival (hRFS)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Overall recurrence free survival (RFS);Secondary end point(s):Overall survival (OS);Secondary end point(s):Postoperative complications;Secondary end point(s):Chemotherapy related adverse events (AEs);Secondary end point(s):Proportion of patients that started with adjuvant HAIP chemotherapy;Secondary end point(s):Quality of life;Secondary end point(s):Cost-effectiveness;Secondary end point(s):Predictive biomarkers for the efficacy of HAIP chemotherapy