drugset / Trial / NCT05863195

Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial

NCT05863195

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.

Timeline

Start
2023-10-19
Primary completion
2029-06-30
Completion
2034-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Floxuridine Unknown Other
Comparator Bevacizumab Monoclonal antibody Intravenous
Background Cetuximab Monoclonal antibody Intravenous
Background Irinotecan Small molecule Intravenous
Background Leucovorin Small molecule Intravenous
Background Oxaliplatin Small molecule Intravenous
Background Panitumumab Monoclonal antibody Intravenous
Background fluorouracil Small molecule Intravenous