Carfilzomib for Liver Metastasis After Prior Hepatic Artery Infusion Pump Therapy
This study is testing a drug called carfilzomib (CFZ) for people with certain cancers that have spread to the liver. These cancers include colorectal cancer, intrahepatic cholangiocarcinoma (a type of bile duct cancer), or adrenocortical carcinoma (a type of adrenal gland cancer). You must have already had a hepatic artery infusion (HAI) pump placed, which delivers medicine directly to your liver. Researchers want to see how safe it is to give carfilzomib through this pump. The study will give carfilzomib continuously for up to 6 cycles. The main goal is to find out if carfilzomib given this way is safe.
- Study design
- This is an open-label study, meaning both you and your doctors will know what treatment you are receiving. It is a single-center study planning to enroll 20 participants.
- What's involved
- You would receive carfilzomib continuously via your hepatic artery infusion pump for up to 6 cycles. Safety will be assessed during the first 28-day cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your adverse events (side effects) will be monitored from the start of the study intervention until 28 days after your last study intervention or the start of a new cancer treatment, whichever comes first.
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NCT07715903
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~20 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Carfilzomib
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Establish the safety of hepatic artery infusion (HAI) of carfilzomib (CFZ) in participants with liver metastatic disease who were previously treated with HAI pump therapy
Measured over DLT assessment will occur during Cycle 1 (28 days total).Assessment of adverse events will occur from the first study intervention through 28 days after the last study intervention or initiation of a new anti-cancer treatment whichever comes first
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Jonathan M Hernandez, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
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).
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
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.
What this trial measures
- Establish the safety of hepatic artery infusion (HAI) of carfilzomib (CFZ) in participants with liver metastatic disease who were previously treated with HAI pump therapyDLT assessment will occur during Cycle 1 (28 days total).Assessment of adverse events will occur from the first study intervention through 28 days after the last study intervention or initiation of a new anti-cancer treatment whichever comes first
The safety of the study therapy will be evaluated by the maximum dosage at which no more than 1 of 6 participants experience DLT during DLT period (Cycle 1) and by reporting the grade and type of toxicity at each dose level