Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Michael J Cavnar, MD
Study ID
NCT07201519
Phase
PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer Metastatic
  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Hepatic Artery Infusion Pump (HAIP) — DEVICE
    HAIP will be filled with mixture of FUDR + Dexamethasone, Heparin \& Saline for a 14 day infusion of drugs, followed by a 14 day infusion of Heparin+Saline.
  • Standard Treatment — PROCEDURE
    systemic therapy per standard-of-care and institutional standards; visits every two weeks and standard manual HAI dose calculation
  • Community Treatment — PROCEDURE
    systemic therapy fill by home infusion based on TO orders. In person visit with CO for systemic chemotherapy with dose recommendations from TO. Locally obtained testing with telehealth visits with TO team.
  • Systemic Chemotherapy Standard of Care — DRUG
    Dosing of systemic therapy will be according to established routine practice guidelines. Patients with colon cancer will receive systemic chemotherapy that will consist of either FOLFIRI, FOLFOX, or Irinotecan/oxaliplatin at the discretion of the oncologist. Patients with intrahepatic cholangiocarcinoma will receive Gemcitabine/Oxaliplatin or Gemcitabine alone, at the discretion of the oncologist.
  • Standard Of Care targeting driver mutations — DRUG
    Per current SOC guidelines, EGFR inhibitors targeting driver mutations (e.g., RAS wild-type) will be administered as appropriate (FDA-approved agents such as Panitumumab for EGFR)

Study Details

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.

Key Dates

Start date
Jan 23, 2026
Status verified
Feb 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tertiary Oncology Cohort (TO)
    receive care as per usual institutional protocol, visits every two weeks and standard manual HAI dose calculation.
  • Experimental: Community Oncology Cohort (CO)
    HAI pump fills in home by a home infusion company; systemic therapy treatments at the community oncology office; oversight via telehealth visits

Primary Outcome Measure

Percent of participants with HAI Pump still in use at 3 months [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506-

Find similar trials in Lexington, KY

By research site
University of Kentucky· Lexington, KY

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