Study of Hepatic Artery Infusion Chemotherapy for Colorectal Cancer Metastatic to Liver or Intrahepatic Cholangiocarcinoma
This study is looking at the safety and practicality of delivering chemotherapy directly to the liver for people with colorectal cancer that has spread to the liver, or with intrahepatic cholangiocarcinoma (a type of bile duct cancer). You would have a pump surgically placed to deliver a mixture of FUDR and Dexamethasone, Heparin, and Saline directly into your hepatic artery (the main blood vessel supplying the liver). The study wants to see if it's safe to have pump refills done at home or a local clinic, rather than always at the hospital. The main goal is to see how many participants still have their pump in use after 3 months. This study is for adults aged 18 to 99 with these specific types of cancer.
- Study design
- This is an interventional study planning to enroll 80 participants. The phase of the study is not specified, and the status is currently unclear.
- What's involved
- Participants will undergo surgery to install a pump. The pump will deliver drugs for 14 days, followed by a 14-day infusion of Heparin and Saline. You may also receive standard systemic chemotherapy and have visits every two weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 3 months, focusing on the pump's use at that time.
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NCT07201519
Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy
Recruiting
PHASE2Ages 18–99InterventionalTreatmentMichael J Cavnar, MDInvestigator-initiated
~80 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Hepatic Artery Infusion Pump (HAIP)Standard TreatmentCommunity TreatmentSystemic Chemotherapy Standard of CareStandard Of Care targeting driver mutations
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of participants with HAI Pump still in use at 3 months
Measured over 3 months
Conditions
Where it's being run
1 sites across 1 statesKentucky1
Study leadership
- Michael Cavnar, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Colorectal adenocarcinoma metastatic to the liver which is either Unresectable (group A) or Resectable (group B; ie, will be completely resected), AND with no definitive clinical or radiographic evidence of extrahepatic disease other than: metastatic disease to resectable peri-hepatic lymph nodes; up to 5 proven or suspected lung metastases, provided they are stable or responding in number and size for a minimum of 2-months of systemic chemotherapy and are amenable to SBRT or resection. or
Histologically confirmed unresectable intrahepatic cholangiocarcinoma (group C), with presence of less than 70% liver involvement with no definitive clinical or radiographic evidence of extrahepatic metastatic disease other than resectable perihepatic lymph nodes.
Patients \> or equal 18 years of age
ECOG Performance Status of 0 - 1 (APPENDIX C)
Lab Values \< or equal 14 days prior to study enrollment: absolute neutrophil count \> or equal 1,500/mcL Total Bilirubin \< or equal 1.5 mg/dL AST/ALT \< 5 x institutional upper limit of normal (ULN) Platelets \> or equal 100,000/mcL Creatinine \< 1.5 mg/dL HGB \> 8 g/dL INR \< or equal 1.5
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Prior chemotherapy is acceptable if last dose given \> or equal 3 weeks prior to study enrollment
Any investigational agent is acceptable if last dose administered \> or equal 3 months before study enrollment
In order for patients to select treatment in the CO arm, they must have the ability to do telehealth visits, either via a home computer, tablet, or smartphone, either via home internet access or cellphone network.
Exclusion
Presence of distant non-liver metastatic disease confirmed by radiographic evaluation. Clinical or radiographic evidence of metastatic disease to regional peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. For the colorectal carcinoma only: Up to 5 lung metastases are allowable, provided they are stable (or responding) in number and size for minimum of 2-mos of systemic chemo and are amenable to SBRT.
Microsatellite instability (MSI) or Mismatch repair deficiency (MMR-D)
Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable
Bevacizumab (Avastin®) cannot be given concurrently with HAI FUDR. Patients can previously have received it with a minimum 6-week washout period
Active infection, hepatic encephalopathy
Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis) are exclusions. Note: surgically-related ascites does not exclude the patient.
Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of childbearing potential must have negative pregnancy test prior to surgery)
If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment
Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy; Patients with a history of stroke within 3 months or with substantial residual deficit, based on investigator discretion
Serious or non-healing active wound, ulcer, or bone fracture
Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the HAIP chemotherapy (i.e., investigational regimen)
Patients with psychiatric illness or social situations that would limit compliance with study requirements. Examples: active substance abuse, active severe alcohol abuse, etc.
Inability to reliably commit to traveling to either Lexington, KY (for patients choosing TO site for HAI administration) or local CO site every 2 weeks for duration of the study treatment (6 months). Patient must have readily identifiable, reliable primary and back-up modes of transportation regardless of weather.
Patients with AXIOS™ stents (or similar) used to connect the small intestine to the gastric remnant after a prior gastric bypass for access for ERCP/stent in the setting of biliary obstruction are eligible at the discretion of the investigator. Considerations regarding eligibility comprise removal of the stent prior to HAIP implantation, or the placement of the HAIP catheter at least 5cm away from the AXIOS stent.
What this trial measures
- Percent of participants with HAI Pump still in use at 3 months3 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.