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Corticosteroid

Systemic chemotherapy for colorectal liver metastases for Colorectal Cancer

N/A
Waitlist Available
Research Sponsored by Michael J Cavnar, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing the safety of a new hepatic artery infusion pump placement, using the Medtronic Synchromed II pump combined with the Codman arterial catheter, in patients with unresectable liver metastases from colorectal cancer and unresectable intrahepatic cholangiocarcinoma.

Eligible Conditions
  • Colorectal Cancer
  • Bile Duct Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy
Secondary outcome measures
30-day Catheter Malfunction Due to Inability to Access Pump
30-day Catheter Malfunction Due to Tubing Disconnect
30-day Postoperative Serious Adverse Events Related to Pump Implantation
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intrahepatic cholangiocarcinomaExperimental Treatment3 Interventions
Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)
Group II: Colorectal liver metastasesExperimental Treatment3 Interventions
Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)

Find a Location

Who is running the clinical trial?

Michael J Cavnar, MDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma
Michael J Cavnar, MD 2020. "Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04276090.
~4 spots leftby Apr 2025
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