Status:
WITHDRAWN
Hepatic Artery Infusion (HAI) Program at Duke University
Lead Sponsor:
Michael Lidsky, M.D.
Conditions:
Metastatic Colon Cancer
Liver Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The Duke HAI program was implemented in November 2018 and treated 30 patients in its first 17 months using the Medtronic Synchromed II device (only commercially available device suitable for HAI for c...
Detailed Description
This protocol is an interventional study for HAI therapy at Duke. The protocol is essentially for clinical treatment and the Investigator is not collecting safety and effectiveness data on the device ...
Eligibility Criteria
Inclusion
- Patients age 18-80
- Eastern Cooperative Oncology Group score 0-1
- Fit for major surgery
- Without evidence of cirrhosis or portal hypertension
- Labs within 14 days of surgery: White blood cells ≥3 k/uL, Absolute Neutrophil Count ≥ 1.5 k/uL, Platelets ≥ 100K /uL, Creatinine ≤ 1.5 mg/dL, Total bilirubin ≤1.5 mg/dL
- Disease should be liver-only or liver-dominant
- Arterial anatomy must be suitable, determined by the surgeon
- Primary tumor may be in place in the case of colorectal liver metastases. Patients may have colorectal liver metastases (unresectable, borderline resectable, resectable), or unresectable intrahepatic cholangiocarcinoma.
- Chemotherapy completed at least 3 weeks prior to surgery.
Exclusion
- Patients younger than 18 or older than 80 years
- Eastern Cooperative Oncology Group score 2+
- Unfit for major surgery
- Inherent liver disease with evidence of cirrhosis or portal hypertension
- Widely metastatic disease is absolutely contraindicated
- Pregnant women (Women of childbearing potential who have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed and have a partner who is able to father children will have a blood or urine pregnancy test performed, and it must be negative in order to continue in the study.)
Key Trial Info
Start Date :
December 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04511793
Start Date
December 11 2020
End Date
December 31 2022
Last Update
July 19 2021
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