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New treatment option for Intrahepatic Bile Duct Cancer
Official title Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery
ClinicalTrials.gov ID: NCT06888063
What this study is testing
What is Hepatic Arterial Infusion Pump chemotherapy with floxuridin?
Hepatic Arterial Infusion Pump chemotherapy with floxuridin is an investigational medicine, being studied as a potential treatment for intrahepatic bile duct cancer.
Also referred to as HAIP, HAIC with floxuridin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are: Does addition of chemotherapy by means of a chemo pump lead to less return of disease within the liver two years after surgery?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years or older
- ECOG or WHO 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...
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...
- Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without...
- 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.
See the full eligibility criteria
- 18 years or older
- ECOG or WHO 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...
- Adequate bone marrow, liver, and renal function before inclusion (values may be max. 30 days old)
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^ 9/L
- White blood cell count (WBC) ≥ 2.5 x 10\^9/L
- Platelets ≥ 100 x 10\^9/L
- Glomerular filtration rate (GFR) ≥ 30 ml/min
- Haemoglobin (Hb) ≥ 5.5 mmol/L
- Total 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 characterize or biopsy are eligible.
- 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.
- Organ allografts requiring immunosuppressive therapy.
- Serious infections (uncontrolled or requiring treatment).
- Participation in another treatment study for iCCA with survival as outcome.
- Participation in another prospective study with an treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, South Holland, Netherlands
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.