Colorectal Cancer MetastaticPhase 2NCT07201519
Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy
A Phase 2 study testing Hepatic Artery Infusion Pump (HAIP), Standard Treatment and Community Treatment in people with Colorectal Cancer Metastatic and Intrahepatic Cholangiocarcinoma, run by Michael J Cavnar, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Cancer Metastatic, Intrahepatic Cholangiocarcinoma
- What is being tested?
- Hepatic Artery Infusion Pump (HAIP), Standard Treatment and Community Treatment
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2026to Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
About this study
Official title: Phase IIa Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy
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
Read more
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.
- Being tested
- Hepatic Artery Infusion Pump (HAIP), Standard Treatment, Community Treatment, Systemic Chemotherapy Standard of Care, Standard Of Care targeting driver mutations
- Keywords
- hepatic artery infusion, chemotherapy, floxuridine
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic Artery Infusion Pump (HAIP)Device
Also called Intera 3000
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 TreatmentProcedure or surgery
Also called Tertiary Oncology (TO)
systemic therapy per standard-of-care and institutional standards; visits every two weeks and standard manual HAI dose calculation
Community TreatmentProcedure or surgery
Also called Community Oncology (CO)
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 CareDrug
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 mutationsDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Tertiary Oncology Cohort (TO) | Active comparator | receive care as per usual institutional protocol, visits every two weeks and standard manual HAI dose calculation. Receives: Device: Hepatic Artery Infusion Pump (HAIP); Procedure: Standard Treatment; Drug: Systemic Chemotherapy Standard of Care; Drug: Standard Of Care targeting driver mutations |
| Community Oncology Cohort (CO) | Experimental | HAI pump fills in home by a home infusion company; systemic therapy treatments at the community oncology office; oversight via telehealth visits Receives: Device: Hepatic Artery Infusion Pump (HAIP); Procedure: Community Treatment; Drug: Systemic Chemotherapy Standard of Care; Drug: Standard Of Care targeting driver mutations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent 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.
Measured: 3 months
Secondary outcomes (7)
Number of Adverse events according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 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
Measured: 3 months
Number of administered HAI cycles
Tabulate the number of administered HAI cycles at 1-year post-enrollment
Measured: 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
Measured: 3 months
Number of participants with biliary sclerosis
biliary sclerosis is determined by the treating physician
Measured: 1 year
Number of participants with biliary sclerosis
biliary sclerosis is determined by the treating physician
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start23 Jan 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael J Cavnar, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael J Cavnar, MD, University of Kentucky
- Investigators
- Michael Cavnar, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201519
- Sponsor's protocol ID
- 102585
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy
- ClinicalTrials.gov ID
- NCT07201519
- Acronym / sponsor ID
- 102585
- Keywords
- hepatic artery infusion, chemotherapy, floxuridine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Michael J Cavnar, MDUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tertiary Oncology Cohort (TO) | Active comparator | Device: Hepatic Artery Infusion Pump (HAIP), Procedure: Standard Treatment, Drug: Systemic Chemotherapy Standard of Care, Drug: Standard Of Care targeting driver mutationsreceive care as per usual institutional protocol, visits every two weeks and standard manual HAI dose calculation. |
| Community Oncology Cohort (CO) | Experimental | Device: Hepatic Artery Infusion Pump (HAIP), Procedure: Community Treatment, Drug: Systemic Chemotherapy Standard of Care, Drug: Standard Of Care targeting driver mutationsHAI pump fills in home by a home infusion company; systemic therapy treatments at the community oncology office; oversight via telehealth visits |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic Artery Infusion Pump (HAIP)Also: Intera 3000HAIP 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. | Device | Community Oncology Cohort (CO), Tertiary Oncology Cohort (TO) |
| Standard TreatmentAlso: Tertiary Oncology (TO)systemic therapy per standard-of-care and institutional standards; visits every two weeks and standard manual HAI dose calculation | Procedure or surgery | Tertiary Oncology Cohort (TO) |
| Community TreatmentAlso: Community Oncology (CO)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. | Procedure or surgery | Community Oncology Cohort (CO) |
| Systemic Chemotherapy Standard of CareDosing 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 | Community Oncology Cohort (CO), Tertiary Oncology Cohort (TO) |
| Standard Of Care targeting driver mutationsPer 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) | Drug | Community Oncology Cohort (CO), Tertiary Oncology Cohort (TO) |
Primary outcome
Percent of participants with HAI Pump still in use at 3 months
Time frame: 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.
7 secondary outcomes
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
Time frame: 3 months
Number of administered HAI cycles
Time frame: 1 year
Number of failed access visits by home infusion
Time frame: 3 months
Number of participants with biliary sclerosis
Time frame: 1 year
Number of participants with biliary sclerosis
Time frame: 2 years
Overall Response Rate (via RECIST v1.1)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Cavnar, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hepatic Artery Infusion Pump (HAIP), Standard Treatment and Community Treatment in people with Colorectal Cancer Metastatic and Intrahepatic Cholangiocarcinoma, run by Michael J Cavnar, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvonne Taul, RN (859-323-2354, yvonne.taul@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants with HAI Pump still in use at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.