Liver tumors targeted directly: old pump, new drug
NCT ID NCT07715903
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adrenocortical carcinoma are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ivosidenib plus mFOLFOXIRI and celecoxib as a treatment for BRAF-targeted therapy-refractory BRAF V600E-mutant colorectal cancer patients: a phase II study
- Can a new drug shrink advanced solid tumors?
- Can a new drug shrink tumors that resist standard care?
- A single blood draw to detect five cancers before symptoms appear?
- Can a new drug duo shrink Hard-to-Treat tumors?
- Could a simple mineral calm the Body's Post-Surgery fire?