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New study pumps chemo directly to liver, lets patients skip hospital visits

NCT ID NCT07201519

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a pump that delivers chemotherapy directly to the liver for people with colorectal cancer or bile duct cancer that has spread to the liver. The goal is to see if the pump is safe and if patients can get their pump refilled at a local clinic instead of always traveling to a big hospital. About 80 participants will have surgery to place the pump and then choose between hospital or community care for about 3-4 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40506, United States

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Other studies related to the condition(s) this trial covers.