Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery

NCT06888063 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: MEC-2024-03242024-513726-33-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intrahepatic Bile Duct Cancer; Intrahepatic Cholangiocarcinoma (Icc); Intrahepatic Bile Duct Carcinoma; Intrahepatic Cholangiocarcinoma

Keywords

PUMP; PUMP IV; Hepatic Arterial Infusion Chemotherapy; Hepatic Arterial Infusion Pump chemotherapy; HAIP; HAIC; Intrahepatic cholangiocarcinoma; iCCA; Floxuridin; Chemopump

Outcome Measures

Primary Outcomes (1)

• 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.

  From pump implantation until 2 years after that surgery

Secondary Outcomes (10)

• Overall recurrence free survival (RFS)

  From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)

• Overall survival (OS)

  From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)

• Post-operative complications

  From pump implantation until 90 days after surgery

• Chemotherapy related adverse events (AEs)

  From inclusion until 4 weeks after the end of treatment with chemotherapy

• Proportion of patients started with HAIP chemotherapy

  From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump

Study Arms (1)

Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy)

EXPERIMENTAL

Surgery + chemo pump

Combination Product: Hepatic Arterial Infusion Pump chemotherapy with floxuridin

Interventions

Hepatic Arterial Infusion Pump chemotherapy with floxuridin COMBINATION_PRODUCT

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

Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify 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 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Koningin Wilhelmina Fonds: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Interventions

Floxuridine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bas Groot Koerkamp, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bas Groot Koerkamp, MD, PhD

CONTACT

+31(0)107031810; b.grootkoerkamp@erasmusmc.nl

Thomas C Zwaan, MD

CONTACT

+31(0)621218051; t.zwaan@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor of Pancreato-Biliary Surgery

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: March 21, 2025
• Study Start: November 20, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2031
• Last Updated: March 21, 2025

Record last verified: 2025-02

Locations

NL (1)