Trials / Recruiting

RecruitingNCT06888063

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

Preventing Liver Recurrence After Partial Hepatectomy for Intrahepatic Cholangiocarcinoma Using Adjuvant Hepatic Arterial Infusion Pump Chemotherapy - PUMP IV Trial

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 40 (estimated)

Sponsor: Erasmus Medical Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)

Timeline

Start date: 2024-11-20
Primary completion: 2026-09-01
Completion: 2031-09-01
First posted: 2025-03-21
Last updated: 2025-03-21

Locations

1 site across 1 country: Netherlands

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06888063. Inclusion in this directory is not an endorsement.