Liver tumors targeted directly: old pump, new drug

NCT ID NCT07715903

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Sep 09, 2026 · Updated 35 times

Summary

This trial tests whether a drug called carfilzomib, given directly to the liver through an implanted pump, is safe for people whose colon, adrenal, or bile duct cancer has spread to the liver and persists after prior pump therapy. Participants receive weekly infusions of the drug via their existing hepatic artery infusion pump for up to six months. The study aims to find the highest safe dose and monitor for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
carfilzomib delivered directly to the liver through a hepatic artery infusion pump
What this could lead to
If it works, this could offer a new treatment option for people with liver metastases that persist after standard HAI pump therapy.
What could go wrong
This is an early, small Phase 1 trial focused on safety, not effectiveness. The drug may not shrink tumors or may cause side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 120 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: * Participants must have a histologically or cytologically confirmed by pathology report diagnosis of colorectal cancer (CRC), intrahepatic cholangiocarcinoma (ICC), or adrenocortical carcinoma (ACC). * Participants must have measurable liver-dominant metastatic disease. Note: liver-dominant metastatic disease is defined as \>=75% of metastatic disease present in the liver as assessed by the principal investigator. * Extrahepatic disease should be treated with anticancer therapy, if applicable, and should be stable by RECIST criteria for at least 6 weeks prior to study treatment initiation. * Participants must have previously undergone hepatic artery infusion pump therapy and have a functioning hepatic artery infusion pump in place. * Participants must have progressed on, been intolerant of, or have residual disease after HAI floxuridine and appropriate current standard-of-care treatment. * Age \>= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2. * Participants must have an adequate organ and marrow function as defined below: Leukocytes \> 3,000/mcL Hemoglobin \>= 9 mg/dL Absolute neutrophil count \> 1,500/mcL Platelets \> 100,000/mcL Total bilirubin \< 2 X institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) \< 2.5 X institutional (ULN) Alanine aminotransferase (ALT) \< 2.5 X institutional (ULN) Creatinine \<2 X institutional (ULN) * Participants positive for human immunodeficiency virus (HIV) 1/2 antibody must have a negative HIV viral load. * Participants positive for Hepatitis C (HCV) antibody must have a negative HCV viral load. * Participants positive for Hepatitis B (HBV) core antibody (HBcAb) must have a negative HBV viral load. Note: Participants positive for Hepatitis B surface antigen (HBsAg) are excluded. * Women of childbearing potential (WOCBP) must agree to use effective contraception (barrier, hormonal, intrauterine device, abstinence, surgical sterilization) at the study entry and up to 6 months after the last dose of the study drug. A participant may request a male partner to use an effective form of contraception to fulfill this requirement (e.g., condom/barrier). Men must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 3 months after the last dose of the study drug. A participant may request a female partner to use an effective form of contraception to fulfill this requirement (e.g., intrauterine device, hormonal contraceptives). Men must not freeze or donate sperm within the same period. * Women who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding from study treatment initiation through 2 weeks after the last dose of the study drug. * Ability of participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Participants with liver metastases amenable to resection. * Participants who received floxuridine within 6 weeks prior to the study treatment initiation. * Participants who received any anticancer therapy within 2 weeks prior to the study treatment initiation. * Participants who received any investigational agents within 4 weeks prior to the study treatment initiation. * Participants with incontrovertible radiographic evidence of disease progression per the RECIST definition outside of the liver within 3 months prior to the study treatment initiation. Note: Pulmonary lesions less than 1 cm are allowed. * Prior radiation to the liver (Yttrium-90 \[Y-90\] or External Beam Radiation Therapy \[EBRT\]). * History of allergic reactions attributed to compounds of similar chemical composition to CFZ. * Positive serum or urine Beta-human chorionic gonadotropin (Beta-HCG) pregnancy test performed at screening. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, evaluated by medical history, electrocardiogram (EKG), physical exam, and laboratory testing, or social situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.

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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.

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  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

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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