Actively Recruiting
Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy
Led by Michael J Cavnar, MD · Updated on 2026-02-04
80
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to help learn about the safety and feasibility of hepatic artery infusion chemotherapy for those who have colorectal liver metastases, both resectable and unresectable, or unresectable intrahepatic cholangiocarcinoma. The main questions it aims to answer are: * safety and feasibility of installing a pump that deliveries chemotherapy to the hepatic artery (the blood vessel that supplies blood to the liver) * help learn more about the safety of patients having pump refills at home or a local clinic versus having it routinely done at the hospital Participants will have surgery to install a pump which is a standard surgical procedure. After surgery, participants will select to either receive treatment at the hospital facility or with a community oncologist that will provide cancer care to participants close to home, rather than in a large hospital or academic medical center. The main treatment on study will last about 3-4 months.
CONDITIONS
Official Title
Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with colorectal adenocarcinoma metastatic to the liver, either unresectable or resectable with no extrahepatic disease except limited lymph node or lung metastases meeting specific stability criteria
- Or histologically confirmed unresectable intrahepatic cholangiocarcinoma with less than 70% liver involvement and no extrahepatic metastatic disease except resectable lymph nodes
- ECOG Performance Status of 0 or 1
- Lab tests within 14 days before enrollment showing specific blood counts and liver and kidney function within defined limits
- HIV-positive patients on effective therapy with undetectable viral load within 6 months
- Patients with chronic hepatitis B must have undetectable viral load on therapy if needed
- Patients with hepatitis C must be treated and cured or have undetectable viral load if currently treated
- Prior chemotherapy allowed if last dose was at least 3 weeks before enrollment
- Prior investigational agents allowed if last dose was at least 3 months before enrollment
- Ability to participate in telehealth visits using a home computer, tablet, or smartphone with internet or cellphone access
You will not qualify if you...
- Presence of distant metastatic disease outside the liver, except allowed stable lung or lymph node metastases
- Microsatellite instability or mismatch repair deficiency
- Prior radiation to the liver (external beam, SBRT, Y90), but prior pelvic radiation allowed
- Concurrent use of Bevacizumab with HAI FUDR; prior Bevacizumab must have a 6-week washout
- Active infection or hepatic encephalopathy
- Clinical signs of portal hypertension (ascites, varices, portal vein thrombosis), except surgical ascites
- Pregnant or lactating women or planning pregnancy within 6 months after treatment; females of childbearing potential must have negative pregnancy test before surgery
- Serious medical problems that would prevent receiving treatment
- History or presence of primary CNS tumors or uncontrolled seizures
- Stroke within 3 months or significant residual deficits
- Serious or non-healing wounds, ulcers, or bone fractures
- Prior or concurrent malignancies that could interfere with safety or efficacy assessment
- Psychiatric or social conditions limiting study compliance
- Inability to reliably travel to treatment sites every 2 weeks for 6 months
- Patients with AXIOS stents eligible only at investigator's discretion with specific conditions regarding stent and catheter placement
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
Research Team
Y
Yvonne Taul, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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