Direct chemotherapy delivery to the liver for bile duct cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of additional chemotherapy administered directly into the liver using a chemo pump in adult patients with resectable intrahepatic bile duct cancer. The study will assess whether this approach can reduce the recurrence of cancer within the liver, improve survival rates, and enhance the quality of life for participants. Patients will receive an implanted chemo pump that delivers chemotherapy directly to the liver following surgical intervention. The trial will monitor outcomes over a two-year period post-surgery.

Why it matters

Who can join: the full rules

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 (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 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

Where it's running

• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Bas Groot Koerkamp, MD, PhD — Erasmus Medical Center
• Study coordinator: Bas Groot Koerkamp, MD, PhD
• Email: b.grootkoerkamp@erasmusmc.nl
• Phone: +31(0)107031810

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.