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
| Verdict | In plain words (machine summary) | Registry text, verbatim | If 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.
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