drugset / Trial / NCT04276090
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Due to discontinuation of the Codman C3000 pump, an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy. This study aims to test the safety of hepatic artery infusion pump placement, a standard surgical procedure, and intraarterial chemotherapy initiation with the standard medication floxuridine (FUDR), using the Medtronic Synchromed II pump combined with the Codman arterial catheter in patients with unresectable (not removable by surgery) liver metastases from colorectal cancer and unresectable intrahepatic cholangiocarcinoma. This study will determine if complication and pump loss rates will be similar to previously published rates for the Codman system.
Timeline
- Start
- 2020-05-01
- Primary completion
- 2022-01-04
- Completion
- 2022-06-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Floxuridine | Unknown | — | Other |
| Background | Dexamethasone | Small molecule | — | Other |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Irinotecan | Small molecule | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | Panitumumab | Monoclonal antibody | — | — |