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Preventing liver recurrence after partial hepatectomy for intrahepatic cholangiocarcinoma using adjuvant hepatic arterial infusion pump chemotherapy – PUMP IV trial
EU CTIS ID: 2024-513726-33-00
What this study is testing
Evaluation of effectiveness of adjuvant HAIP chemotherapy in patient with resectable intrahepatic CCA.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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: o Absolute neutrophil count (ANC) ≥ 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) ≥ 30 ml/min o Haemoglobin (Hb) ≥ 5.5 mmol/L o Total bilirubin ≤ 25 µmol/L
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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: o Absolute neutrophil count (ANC) ≥ 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) ≥ 30 ml/min o Haemoglobin (Hb) ≥ 5.5 mmol/L o Total bilirubin ≤ 25 µmol/L
- Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations
What rules you out
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.