Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy
NCT ID: NCT07201519
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-12-31
2030-02-28
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tertiary Oncology Cohort (TO)
receive care as per usual institutional protocol, visits every two weeks and standard manual HAI dose calculation.
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.
Standard Treatment
systemic therapy per standard-of-care and institutional standards; visits every two weeks and standard manual HAI dose calculation
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.
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)
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
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.
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.
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.
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)
Interventions
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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.
Standard Treatment
systemic therapy per standard-of-care and institutional standards; visits every two weeks and standard manual HAI dose calculation
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.
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.
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Michael J Cavnar, MD
OTHER
Responsible Party
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Michael J Cavnar, MD
Associate Professor
Principal Investigators
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Michael Cavnar, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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Central Contacts
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Other Identifiers
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102585
Identifier Type: -
Identifier Source: org_study_id