Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With … (NCT06888063) | Clinical Trial Compass
RecruitingPhase 2
Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery
Netherlands40 participantsStarted 2024-11-20
Plain-language summary
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?
* Does addition of chemotherapy by means of a chemo pump lead to longer survival of patients?
* Does addition of chemotherapy by means of a chemo pump lead to an increase in quality of life?
Participants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 arteries are no contraindication for catheter placement.
* 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.
Exclusion Criteria:
* 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 (DPY…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Two-year hepatic recurrence free survival (hRFS)
Timeframe: From pump implantation until 2 years after that surgery