RecruitingPhase 2NCT06888063

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


Sponsor

Erasmus Medical Center

Enrollment

40 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study adds chemotherapy delivered directly into the liver's blood supply (via a pump implanted during surgery) to standard treatment for people with a type of bile duct cancer located inside the liver that can be surgically removed. The goal is to reduce the chance the cancer comes back. **You may be eligible if...** - You are 18 or older - You have bile duct cancer inside the liver (intrahepatic cholangiocarcinoma) that appears removable by surgery on imaging scans - You are healthy enough to undergo open abdominal surgery - The anatomy of your liver's blood supply makes pump placement technically possible **You may NOT be eligible if...** - Your cancer has spread outside the liver - You have significant other health problems that make surgery too risky - You have certain blood vessel abnormalities that prevent safe pump placement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTHepatic 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)


Locations(1)

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06888063


Related Trials