MedTrace Logo

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

NCT06888063 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-21

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Bas Groot Koerkamp, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2026-09-30
Completion
2031-09-30
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06888063 on ClinicalTrials.gov