A Phase 2 interventional study of Hepatic Arterial Infusion Pump chemotherapy with floxuridin in Intrahepatic Bile Duct Cancer, Intrahepatic Cholangiocarcinoma (Icc) and Intrahepatic Bile Duct Carcinoma, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Erasmus Medical Center · Phase 2, Interventional, and Treatment
Among 32 studies in Cholangiocarcinoma with a site in Netherlands — 11 open to participants now, 17 under way, 5 of them phase 3. Cholangiocarcinoma · Netherlands.
Among the 32 studies in Cholangiocarcinoma with a site in Netherlands, this one is the 22nd largest by planned enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2024, is one of 8 in phase 2, reaches primary completion later than 12 of the 16 other live ones, and was the 26th registered.
824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.
Browse Cholangiocarcinoma studies →11 of the 32 studies in Cholangiocarcinoma with a site in Netherlands are open now. Recruiting first, the newest first:
Amsterdam UMC, location VUmc · Sites in Netherlands
Ages 18+
Erasmus Medical Center · Sites in Netherlands
Ages 18+
Eli Lilly and Company · Sites in Netherlands, United States, China and 2 more countries
Ages 18+
Alentis Therapeutics AG · Sites in Netherlands, United States, France and 5 more countries
Ages 18+
Maastricht University · Sites in Netherlands, United States, Australia and 9 more countries
Ages 18+
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 211 Cholangiocarcinoma studies recruiting now, 141 (67%) set no upper age limit and 49 (23%) stop at 75 or younger; 10 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 16 · Phase 3 9
First in 2014; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 50 across 623 interventional studies indexed under Cholangiocarcinoma.
Median enrollment 173 across the 27 interventional studies, 245 across the 5 observational. Of the 15 that completed or were terminated, 7 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 32 have an industry lead sponsor. The 10 most frequent:
Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
Erasmus Medical Center has 3 studies filed under Cholangiocarcinoma — fewer than ten, so there is no comparison to draw.
5 of the studies in Cholangiocarcinoma with a site in Netherlands that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05948475Phase 3TransThera Sciences (Nanjing), Inc.Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma | 2026-12 |
| NCT06355427Phase 3Mara Veenstra, MDThe Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma | 2027-09-01 |
| NCT04891289Memorial Sloan Kettering Cancer CenterGemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery | 2027-05 |
| NCT02568267Hoffmann-La RocheBasket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) | 2027-06-30 |
| NCT07717437Maastricht University Medical CenterDRAGON Registry - International Multicenter Registry and Medical Image Bank for Patients With Primarily Unresectable Liver Cancer or Liver Metastases That Underwent Combined Portal and Hepatic Vein Embolization (PVE/HVE) to Increase Future Liver Remnant Before Resection. | 2027-11-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 32 studies in Cholangiocarcinoma with a site in Netherlands, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Participants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgery + chemo pump
Combination Product: Hepatic Arterial Infusion Pump chemotherapy with floxuridin
Participants in this arm will receive in addition to standard care (surgery) a chemo pump. This pump will provide participants with 4 cycles of treatment with chemotherapy (Floxuridin), each lasting 4 weeks. Total treatment with chemotherapy will last 16 weeks (approx. 4 months)
Also known as: HAIP, HAIC with floxuridin, PUMP chemotherapy
Two-year hepatic recurrence free survival (hRFS)
The percentage of patients who do not have return of disease in the liver two years after surgery. The time frame is defined as the period between pump implantation and return of disease in the liver. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples.
Time frame: From pump implantation until 2 years after that surgery
Overall recurrence free survival (RFS)
The percentage of patients who do not have return of disease in the given time frame. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples.
Time frame: From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)
Overall survival (OS)
OS is defined as the interval between pump implantation and the date of death (by any cause) or date of last follow-up
Time frame: From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)
Post-operative complications
All complications rated Clavien-Dindo grade 3 or higher are recorded for the first 90 days after surgery.
Time frame: From pump implantation until 90 days after surgery
Chemotherapy related adverse events (AEs)
Chemotherapy related adverse events (AEs) will be collected if they are grade III or higher according to CTCAE version 5.0
Time frame: From inclusion until 4 weeks after the end of treatment with chemotherapy
Proportion of patients started with HAIP chemotherapy
The number of patients that could receive at least 1 cycle of HAIP chemotherapy with floxuridin
Time frame: From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump
Quality of life: EORTC QLQ-30
After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This validated instrument includes 30 items covering functional domains, symptom scales, and global health status. Scores range from 0 to 100, with higher scores on the global health and functional scales indicating better quality of life. After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years.
Time frame: From inclusion until 5 years after surgery
Quality of life: EQ-5D
After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the EuroQol 5-Dimension (EQ-5D) questionnaire, a standardized measure of health-related quality of life. The EQ-5D includes five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The resulting health state is converted into an index score ranging from 0 (equivalent to death) to 1 (perfect health), though negative scores are possible. After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years.
Time frame: From inclusion until 5 years after surgery
Cost-effectiveness
An assessment of the cost-effectiveness of HAIP chemotherapy for patients with iCCA will be made
Time frame: From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome)
Predictive biomarkers in the blood for efficacy of HAIP chemotherapy
A total of five additional blood samples will be collected. These samples will be collected: * On the day of surgery before the incision is made. * During surgery (directly from the hepatic vein). * Before the start of HAIP chemotherapy. * After the last cycle of HAIP chemotherapy. * At one year after surgery or at recurrence
Time frame: From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first)
Predictive biomarkers from liver tissue for efficacy of HAIP chemotherapy
Additionally, tumor tissue will be collected from the removed part of the liver during the surgery. These tissue samples will be stored for further research into biomarkers.
Time frame: From resection until 25 years after (conform applicable laws)
Plan to share: Undecided — The decision on sharing IPD has not been made within the trial team. Once this decision is made, we will update this part.
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Sep 2028, 46 months after the start.
Of 147 non-industry phase 2 interventional studies under Cholangiocarcinoma, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 65. This study's planned 46 months is close to that.
Counting every sponsor, half of 173 studies reached it within 46 months; a quarter within 29 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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