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

Study acronym: PUMP IV
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Sep 2026 → Sep 2028
See other at-risk trials from Erasmus Medical Center

Record History

  1. Primary completion pushed from Sep 2026 to Sep 2028 Completion pushed from Sep 2031 to Sep 2033 · Eligibility criteria expanded, about 27 words · Secondary endpoints: details revised at 5 of 10 entries Show 3 more changesShow less
    • Completion pushed from Sep 2031 to Sep 2033
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 5 of 10 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06888063
Lead Sponsor Erasmus Medical Center
Collaborators: Koningin Wilhelmina Fonds
Conditions Intrahepatic Bile Duct Cancer, Intrahepatic Cholangiocarcinoma (Icc), Intrahepatic Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov