Cancer Help Guide

Adrenocortical carcinoma · NCT07715903

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

Phase I Study Evaluating Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy

Status
NOT_YET_RECRUITING (ClinicalTrials.gov)Not yet recruiting
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Registry records
CTGOV NCT07715903 (NOT_YET_RECRUITING)
Registry last updated 2026-11-06

Eligibility, line by line

VerdictIn plain words (machine summary)Registry text, verbatimIf unmet
inclusion
inclusion · condition · confidence 0.97
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 a histologically or cytologically confirmed by pathology report diagnosis of colorectal cancer (CRC), intrahepatic cholangiocarcinoma (ICC), or adrenocortical carcinoma (ACC)."
inclusion
inclusion · lesion burden · confidence 0.95
Participants must have measurable liver-dominant metastatic disease."Participants must have measurable liver-dominant metastatic disease."
inclusion
inclusion · stage extent · confidence 0.80
Liver-dominant metastatic disease is defined as >=75% of metastatic disease present in the liver as assessed by the principal investigator."liver-dominant metastatic disease is defined as \>=75% of metastatic disease present in the liver as assessed by the principal investigator"
inclusion
inclusion · stage extent · confidence 0.85
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."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."
inclusion
inclusion · prior therapy · confidence 0.95
Participants must have previously undergone hepatic artery infusion pump therapy and have a functioning hepatic artery infusion pump in place."Participants must have previously undergone hepatic artery infusion pump therapy and have a functioning hepatic artery infusion pump in place."
inclusion
inclusion · prior therapy · confidence 0.80
Participants must have progressed on, been intolerant of, or have residual disease after HAI floxuridine and appropriate current standard-of-care treatment."Participants must have progressed on, been intolerant of, or have residual disease after HAI floxuridine and appropriate current standard-of-care treatment."
inclusion
inclusion · age sex · confidence 0.98
Age >= 18 years."Age \>= 18 years."
inclusion
inclusion · performance status · confidence 0.98
Eastern Cooperative Oncology Group (ECOG) performance status <= 2."Eastern Cooperative Oncology Group (ECOG) performance status \<= 2."
inclusion
inclusion · lab value · confidence 0.97
Leukocytes > 3,000/mcL"Leukocytes \> 3,000/mcL"
inclusion
inclusion · lab value · confidence 0.97
Hemoglobin >= 9 mg/dL"Hemoglobin \>= 9 mg/dL"
inclusion
inclusion · lab value · confidence 0.97
Absolute neutrophil count > 1,500/mcL"Absolute neutrophil count \> 1,500/mcL"
inclusion
inclusion · lab value · confidence 0.97
Platelets > 100,000/mcL"Platelets \> 100,000/mcL"
inclusion
inclusion · lab value · confidence 0.97
Total bilirubin < 2 X institutional upper limit of normal (ULN)"Total bilirubin \< 2 X institutional upper limit of normal (ULN)"
inclusion
inclusion · lab value · confidence 0.97
Aspartate aminotransferase (AST) < 2.5 X institutional (ULN)"Aspartate aminotransferase (AST) \< 2.5 X institutional (ULN)"
inclusion
inclusion · lab value · confidence 0.97
Alanine aminotransferase (ALT) < 2.5 X institutional (ULN)"Alanine aminotransferase (ALT) \< 2.5 X institutional (ULN)"
inclusion
inclusion · lab value · confidence 0.97
Creatinine <2 X institutional (ULN)"Creatinine \<2 X institutional (ULN)"
inclusion
inclusion · comorbidity · confidence 0.30
Participants positive for human immunodeficiency virus (HIV) 1/2 antibody must have a negative HIV viral load."Participants positive for human immunodeficiency virus (HIV) 1/2 antibody must have a negative HIV viral load."
inclusion
inclusion · comorbidity · confidence 0.30
Participants positive for Hepatitis C (HCV) antibody must have a negative HCV viral load."Participants positive for Hepatitis C (HCV) antibody must have a negative HCV viral load."
inclusion
inclusion · comorbidity · confidence 0.30
Participants positive for Hepatitis B (HBV) core antibody (HBcAb) must have a negative HBV viral load."Participants positive for Hepatitis B (HBV) core antibody (HBcAb) must have a negative HBV viral load."
exclusion
exclusion · comorbidity · confidence 0.90
Participants positive for Hepatitis B surface antigen (HBsAg) are excluded."Participants positive for Hepatitis B surface antigen (HBsAg) are excluded."
inclusion
inclusion · pregnancy contraception · confidence 0.30
Women of childbearing potential (WOCBP) must agree to use effective contraception at the study entry and up to 6 months after the last dose of the study drug."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."
inclusion
inclusion · pregnancy contraception · confidence 0.30
Men must agree to use an effective method of contraception at the study entry and up to 3 months after the last dose of the study drug. Men must not freeze or donate sperm within the same period."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."
inclusion
inclusion · pregnancy contraception · confidence 0.30
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."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."
inclusion
inclusion · consent · confidence 0.30
Ability of participant to understand and the willingness to sign a written informed consent document."Ability of participant to understand and the willingness to sign a written informed consent document."
exclusion
exclusion · stage extent · confidence 0.90
Participants with liver metastases amenable to resection."Participants with liver metastases amenable to resection."
exclusion
exclusion · washout · confidence 0.95
Participants who received floxuridine within 6 weeks prior to the study treatment initiation."Participants who received floxuridine within 6 weeks prior to the study treatment initiation."
exclusion
exclusion · washout · confidence 0.95
Participants who received any anticancer therapy within 2 weeks prior to the study treatment initiation."Participants who received any anticancer therapy within 2 weeks prior to the study treatment initiation."
exclusion
exclusion · washout · confidence 0.95
Participants who received any investigational agents within 4 weeks prior to the study treatment initiation."Participants who received any investigational agents within 4 weeks prior to the study treatment initiation."
exclusion
exclusion · stage extent · confidence 0.85
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."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."
exclusion
exclusion · prior therapy · confidence 0.95
Prior radiation to the liver (Yttrium-90 [Y-90] or External Beam Radiation Therapy [EBRT])."Prior radiation to the liver (Yttrium-90 \[Y-90\] or External Beam Radiation Therapy \[EBRT\])."
exclusion
exclusion · comorbidity · confidence 0.90
History of allergic reactions attributed to compounds of similar chemical composition to CFZ."History of allergic reactions attributed to compounds of similar chemical composition to CFZ."
exclusion
exclusion · pregnancy contraception · confidence 0.95
Positive serum or urine Beta-human chorionic gonadotropin (Beta-HCG) pregnancy test performed at screening."Positive serum or urine Beta-human chorionic gonadotropin (Beta-HCG) pregnancy test performed at screening."
exclusion
exclusion · comorbidity · confidence 0.90
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or social situations that would unacceptably increase risk or limit compliance."Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia"

Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.

Full eligibility text as the registry publishes it
* 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.

Routes in: how this trial is reached and paid for

  • NIH Clinical Center: care at no cost, travel supported

    Medical care at the NIH Clinical Center in Bethesda is provided at no cost to people enrolled on a study, and travel and lodging support is available, including for people living outside the US.

    For non-US residents NIH provides airfare from the nearest US point of entry and a nightly hotel allowance. That makes Bethesda cheaper to reach than most US hospitals despite the distance. Ask the study contact what the current travel policy covers before booking anything.

    Verify with: NIH Clinical Center: participating in a study

    Care 0; transatlantic flight at your own cost, then supported

  • Free patient navigation

    myTomorrows (Amsterdam) provides medically trained, multilingual patient navigators who search ClinicalTrials.gov, EU CTIS and ISRCTN and can support a doctor through an expanded-access application. Free to patients and families.

    A navigator keeps searching after any single page stops being current. Use it alongside this site, not instead of your oncologist.

    Verify with: myTomorrows for patients

    0

Sites (1)

United States

  • National Institutes of Health Clinical Center, Bethesda