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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
systemic therapy per standard-of-care and institutional standards; visits every two weeks and standard manual HAI dose calculation
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.
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.
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)
University of Kentucky
Lexington, Kentucky, United States
RECRUITINGPercent of participants with HAI Pump still in use at 3 months
The primary outcome is safety, defined as: continued functional / in-use HAI pump (either for FUDR fills or maintenance saline/glycerine fills) at 3-months.
Time frame: 3 months
Number of Adverse events according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 4 months
Number of participants transferring care
Determine the number of Community Oncology (CO) HAI patients that permanently transfer their care to tertiary center due to CO access issues or other reasons
Time frame: 3 months
Number of administered HAI cycles
Tabulate the number of administered HAI cycles at 1-year post-enrollment
Time frame: 1 year
Number of failed access visits by home infusion
Home infusion HAI access issues for Cycles 1 - 3, assessed by the number of failed access visits by home infusion requiring a trip to the institution for pump access/troubleshooting
Time frame: 3 months
Number of participants with biliary sclerosis
biliary sclerosis is determined by the treating physician
Time frame: 1 year
Number of participants with biliary sclerosis
biliary sclerosis is determined by the treating physician
Time frame: 2 years
Overall Response Rate (via RECIST v1.1)
In patients with measurable disease (unresectable CLM and unresectable intrahepatic cholangiocarcinoma, measure Overall Response Rate (via RECIST v1.1) to standard hepatic artery infusion chemotherapy (FUDR) combined with standard systemic chemotherapy (tailored to primary disease), and conversion to resection at 1-year post-study enrollment.
Time frame: 3 months
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