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

NCT07201519 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-04

No results posted yet for this study

Summary

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

  • Colorectal Cancer Metastatic
  • Intrahepatic Cholangiocarcinoma

Interventions

DEVICE

Hepatic Artery Infusion Pump (HAIP)

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.

PROCEDURE

Standard Treatment

systemic therapy per standard-of-care and institutional standards; visits every two weeks and standard manual HAI dose calculation

PROCEDURE

Community Treatment

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.

DRUG

Systemic Chemotherapy Standard of Care

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.

DRUG

Standard Of Care targeting driver mutations

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)

Sponsors & Collaborators

  • Michael J Cavnar, MD

    lead OTHER

Principal Investigators

  • Michael Cavnar, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-23
Primary Completion
2028-02-29
Completion
2030-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201519 on ClinicalTrials.gov