Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy

Official record

Identifier

NCT07715903

Recruiting locations

country

United States

Interventions studied

Carfilzomib

Lead sponsor

National Cancer Institute (NCI)

Target enrolment

20 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Not yet recruiting

First posted

Jul 21, 2026

Last updated on the registry

Jul 31, 2026

Age

18 Years – 120 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

* 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.

Indexed under

Colorectal Cancer