NCT07201519

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Michael J Cavnar, MD · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2026-01-23
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2025-10-01
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study