Carfilzomib given into the liver for cancer that has spread there
Tests carfilzomib through a liver pump in adults with cancer spread to the liver.
Key facts
- Who runs it
- National Cancer Institute (NCI)
- Where
- Bethesda, United StatesSee the site
- Trial code
- Registry title
- Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
- Status
- Not yet recruiting
- Phase
- Phase 1
- People taking part
- 20 people, planned
- Starts
- 18 Nov 2026
- Expected to end
- 31 Dec 2031
- Type of study
- Interventional
- Treatments tested
- Carfilzomib
- Record updated
- 13 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal cancer, intrahepatic cholangiocarcinoma or adrenocortical carcinoma that mostly sits in the liver and who already have a working hepatic artery infusion pump.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Colorectal cancer, intrahepatic cholangiocarcinoma or adrenocortical carcinoma confirmed by pathology. Measurable liver-dominant metastatic disease (at least 75% of the spread in the liver). Liver tumors that cannot be removed by surgery.
- Earlier treatment
- Must have had hepatic artery infusion pump therapy and have a working pump in place. Must have progressed on, not tolerated, or have leftover disease after HAI floxuridine and current standard treatment. Disease outside the liver must be treated and stable for at least 6 weeks.
- Biomarker or test result
- People with HIV, hepatitis C or hepatitis B core antibody must have a negative viral load. People with hepatitis B surface antigen cannot join.
Main reasons for not taking part
- Liver metastases that can be removed by surgery
- Floxuridine within 6 weeks, any anticancer therapy within 2 weeks, or an investigational drug within 4 weeks before starting
- Clear disease growth outside the liver within the past 3 months
- Earlier radiation to the liver (Y-90 or EBRT)
- Positive pregnancy test at screening
The registry criteria, word for word
Show all 24 criteriaShow less
Who cannot take part
- 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
Other criteria
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesContact: National Cancer Institute Referral OfficeNot yet recruiting
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
Cancers that begin in the colon, adrenal glands, or bile ducts may spread to the liver. These liver tumors are often treated using a hepatic artery infusion (HAI) pump. The HAI pump is installed in the artery that goes to the liver; drugs are administered directly to the liver through this pump. But these tumors often return after treatment. Carfilzomib (CFZ) is a drug approved to treat another kind of cancer. Researchers want to find out if this drug may be helpful when administered through the HAI pump directly to the liver for people with colon, adrenal glands, or bile duct cancer that has spread to the liver.
Objective:
To test the safety of carfilzomib (CFZ) delivered via a hepatic artery infusion (HAI) pump directly to the liver in people with cancer in their liver.
Eligibility:
People aged 18 years or older with cancers of the colon, adrenal glands, or bile ducts that spread to the liver and persist after treatment. They must have a functioning hepatic artery infusion (HAI) pump in place from previous treatment of HAI pump therapy.
Design:
Participants will be screened. They will have a physical exam, blood tests, imaging scans, and a test of their heart function. They will also have a test to show how the blood flows through their liver: A radioactive substance will be injected into a vein, and a special camera will take pictures of the blood flow for up to 1 hour.
Participants will receive the study drug for about 6 months. They will visit the clinic once a week. Their HAI pump will be filled with the drug at each visit; the drug will slowly drain from the pump into the liver. Blood tests and imaging scans will be repeated during the study.
Participants will have follow-up visits 1 and 3 months after their last dose of study drug.
An optional liver biopsy (tissue sample) for research purposes may be done before the study drug is given, and again (optional) within 28 days after first receiving the study drug. Individuals may participate in the study even if they do not agree to have the biopsies done.
...
The group in the trial
- 1/Phase ITreatment being tested
Participants with liver metastatic disease will receive continuous administration of carfilzomib via Hepatic Artery Infusion Pump (HAIP)
Treatment: Carfilzomib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase I Study Evaluating Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
- Plain-language title
- Carfilzomib given into the liver for cancer that has spread thereGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07715903, who can take part
- Record updated
- 13 November 2026