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ID

44496

Descrizione

Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib; ODM derived from: https://clinicaltrials.gov/show/NCT01217034

collegamento

https://clinicaltrials.gov/show/NCT01217034

Keywords

  1. 16/05/20 16/05/20 -
  2. 27/09/21 27/09/21 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

27 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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    Eligibility Hepatocellular Carcinoma NCT01217034

    Eligibility Hepatocellular Carcinoma NCT01217034

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients aged 20 years or over
    Descrizione

    Age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. patients who were fully informed of the study beforehand and signed the informed consent to participate in the study.
    Descrizione

    Informed Consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    3. patients who are expected to live more than 12 weeks.
    Descrizione

    Life Expectancy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    4. patients diagnosed with typical hcc by biopsy,cytology, or diagnostic imaging such as dynamic ct(mri).typical hcc is defined by aasld criteria.
    Descrizione

    Liver carcinoma Biopsy | Liver carcinoma Diagnostic Imaging | Liver carcinoma CT | Liver carcinoma MRI

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C2239176
    UMLS CUI [1,2]
    C0005558
    UMLS CUI [2,1]
    C2239176
    UMLS CUI [2,2]
    C0011923
    UMLS CUI [3,1]
    C2239176
    UMLS CUI [3,2]
    C0040405
    UMLS CUI [4,1]
    C2239176
    UMLS CUI [4,2]
    C0024485
    5. patients in whom complete resection of the tumor by hepatectomy or complete tumor necrosis by local tumor necrosis therapy(rfa) cannot be expected to succeed.
    Descrizione

    Hepatectomy Unsuccessful | Radiofrequency ablation Unsuccessful

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0019144
    UMLS CUI [1,2]
    C1272705
    UMLS CUI [2,1]
    C0850292
    UMLS CUI [2,2]
    C1272705
    6. patients with tumors which are confirmed to the liver and can be treated by tace(the maximum diameter equal to or less than 10cm,and the maximum number of nodule equal to or less than 10).
    Descrizione

    Transarterial Chemoembolization Liver tumors | Tumor Diameter Maximum | Nodules Quantity Maximum

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3539919
    UMLS CUI [1,2]
    C0023903
    UMLS CUI [2,1]
    C0027651
    UMLS CUI [2,2]
    C1301886
    UMLS CUI [2,3]
    C0806909
    UMLS CUI [3,1]
    C0028259
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [3,3]
    C0806909
    7. patients with viable and measurable target lesion.
    Descrizione

    Target Lesion Measurable

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C2986546
    UMLS CUI [1,2]
    C1513040
    8. patients with no or one history of tace therapy.
    Descrizione

    Transarterial Chemoembolization Absent | Transarterial Chemoembolization Quantity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3539919
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C3539919
    UMLS CUI [2,2]
    C1265611
    9. patients with an ecog ps(performance status) score of 0 or 1.
    Descrizione

    ECOG performance status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    10. patients with child-pugh class a.
    Descrizione

    Child-Pugh Classification

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C4050412
    11. patients with laboratory values that meet the following criteria:
    Descrizione

    Laboratory Results Fulfill Criteria

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1550543
    UMLS CUI [1,3]
    C0243161
    1. hemoglobin ≥ 8.5 g/dl
    Descrizione

    Hemoglobin measurement

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    2. granulocytes ≥ 1500/mm3
    Descrizione

    Granulocyte count

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0857490
    3. platelet count ≥ 50,000 /mm3
    Descrizione

    Platelet Count measurement

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    4. total serum bilirubin ≤ 3 mg/dl
    Descrizione

    Serum total bilirubin measurement

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    5. ast and alt ≤ 6 times upper limits of normal
    Descrizione

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    6. serum creatinine ≤ 1.5 times upper limits of normal
    Descrizione

    Creatinine measurement, serum

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. history of malignant tumor, excluding the following cases:
    Descrizione

    Malignant Neoplasms

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    1. curatively treated early stage cancer with a low risk of recurrence ,such as carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumor, and early gastric cancer.
    Descrizione

    Exception Curative treatment Early stage cancer | Exception Low Risk Recurrent tumor | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Early gastric cancer

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1705847
    UMLS CUI [1,2]
    C1273390
    UMLS CUI [1,3]
    C1517886
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C3538919
    UMLS CUI [2,3]
    C0521158
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0851140
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0007117
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C1336527
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0349530
    2. malignant tumor that was curatively treated more than 3 years prior to study entry and has not recurred since then
    Descrizione

    Exception Curative treatment Malignant Neoplasm | Exception Recurrent tumor Absent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1705847
    UMLS CUI [1,2]
    C1273390
    UMLS CUI [1,3]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0521158
    UMLS CUI [2,3]
    C0332197
    2. cardiac disease that meet any of the following criteria:
    Descrizione

    Heart Disease | Criteria Any Fulfill

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    UMLS CUI [2,1]
    C0243161
    UMLS CUI [2,2]
    C1552551
    UMLS CUI [2,3]
    C1550543
    1. nyha class iii or higher congestive heart failure
    Descrizione

    Congestive heart failure New York Heart Association Classification

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0018802
    UMLS CUI [1,2]
    C1275491
    2. history of symptomatic coronary artery disease or myocardial infarction within 6 months before enrollment
    Descrizione

    Coronary Artery Disease Symptomatic | Myocardial Infarction

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1956346
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [2]
    C0027051
    3. arrhythmia requiring control by antiarrhythmic drugs such as beta-blockers or digoxin
    Descrizione

    Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists Required | Digoxin Required

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0003811
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0003195
    UMLS CUI [2,1]
    C0304516
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [3,1]
    C0012265
    UMLS CUI [3,2]
    C1514873
    3. serious and active infection, except for hbv and hcv
    Descrizione

    Communicable Disease Serious | Exception Hepatitis B | Exception Hepatitis C

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0019163
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0019196
    4. history of hiv infection
    Descrizione

    HIV Infection

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    5. renal dialysis
    Descrizione

    Hemodialysis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0019004
    6. diffuse tumor lesion
    Descrizione

    Tumor Diffuse Lesion

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C1707743
    7. extrahepatic metastasis
    Descrizione

    Neoplasm Metastasis Extrahepatic

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0027627
    UMLS CUI [1,2]
    C1517058
    8. vascular invasion
    Descrizione

    Vascular Invasion

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0521157
    9. intracranial tumor
    Descrizione

    Neoplasms, Intracranial

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1527390
    10. preexisting or history of hepatic encephalopathy
    Descrizione

    Hepatic Encephalopathy Pre-existing | Hepatic Encephalopathy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0019151
    UMLS CUI [1,2]
    C2347662
    UMLS CUI [2]
    C0019151
    11. clinically uncontrolled ascites or pleural effusion
    Descrizione

    Ascites Uncontrolled | Pleural effusion Uncontrolled

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0003962
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C0032227
    UMLS CUI [2,2]
    C0205318
    12. clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
    Descrizione

    Gastrointestinal Hemorrhage Severe

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0017181
    UMLS CUI [1,2]
    C0205082
    13. esophageal and/or gastric varices which has high risk of bleeding
    Descrizione

    Esophageal Varices | Gastric Varices | High risk of bleeding

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0014867
    UMLS CUI [2]
    C0017145
    UMLS CUI [3]
    C4039184
    14. history of thrombosis and/or embolism within 6 months of the start of treatment
    Descrizione

    Thrombosis | Embolism

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0040053
    UMLS CUI [2]
    C0013922
    15. history of receiving any of the following therapies:
    Descrizione

    Therapy Specified Any

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0205369
    UMLS CUI [1,3]
    C1552551
    1. systemic chemotherapy for advanced hcc(including sorafenib therapy)
    Descrizione

    Systemic Chemotherapy Advanced Adult Hepatocellular Carcinoma | sorafenib

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1883256
    UMLS CUI [1,2]
    C1706732
    UMLS CUI [2]
    C1516119
    2. local therapy, such as radiofrequency ablation, tace, or hepatic arterial infusion within 3 months of the start of treatment
    Descrizione

    Local Therapy | Radiofrequency ablation | Transarterial Chemoembolization | Hepatic arterial infusion

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1517925
    UMLS CUI [2]
    C0850292
    UMLS CUI [3]
    C3539919
    UMLS CUI [4]
    C1134564
    3. current treatment with cyp3a4 inducing agents
    Descrizione

    CYP3A4 Inducers

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3850041
    4. invasive surgery within 4 weeks of the start of treatment
    Descrizione

    Surgery invasive

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0348025
    5. history of allogenic transplantation
    Descrizione

    Transplantation, Homologous

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0040739
    6. history of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study
    Descrizione

    Bone Marrow Transplantation | Hemopoietic stem cell transplant

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005961
    UMLS CUI [2]
    C0472699
    16. unable to take oral medications
    Descrizione

    Lacking Able to swallow Oral medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0332268
    UMLS CUI [1,2]
    C2712086
    UMLS CUI [1,3]
    C0175795
    17. gastrointestinal problems that may affect absorption or pharmacokinetics of the study drugs
    Descrizione

    Gastrointestinal problem Affecting Absorption Investigational New Drugs | Gastrointestinal problem Affecting Pharmacokinetics Investigational New Drugs

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0017187
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0237442
    UMLS CUI [1,4]
    C0013230
    UMLS CUI [2,1]
    C0017187
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0031327
    UMLS CUI [2,4]
    C0013230
    18. use of drugs that may affect absorption or pharmacokinetics of the study drugs
    Descrizione

    Drugs Affecting Absorption Investigational New Drugs | Drugs Affecting Pharmacokinetics Investigational New Drugs

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0237442
    UMLS CUI [1,4]
    C0013230
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0031327
    UMLS CUI [2,4]
    C0013230
    19. concurrent disease or disability that may affect evaluation of the effects of the study drugs
    Descrizione

    Comorbidity Affecting Evaluation Investigational New Drugs

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C1261322
    UMLS CUI [1,4]
    C0013230
    20. enrollment in another study within 4 weeks of study entry
    Descrizione

    Study Subject Participation Status | Clinical Trial

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0008976
    21. female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant
    Descrizione

    Pregnancy | Breast Feeding | Possible pregnancy | Pregnancy, Planned

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0425965
    UMLS CUI [4]
    C0032992
    22. risk of allergic reactions to the study drugs
    Descrizione

    Risk Allergic Reaction Investigational New Drugs

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0035647
    UMLS CUI [1,2]
    C1527304
    UMLS CUI [1,3]
    C0013230
    23. drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
    Descrizione

    Drug abuse Interferes with Study Subject Participation Status | Drug abuse Interferes with Evaluation Research results | Physical handicap problem | Mental problem | Social Problem

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0013146
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C2348568
    UMLS CUI [2,1]
    C0013146
    UMLS CUI [2,2]
    C0521102
    UMLS CUI [2,3]
    C1261322
    UMLS CUI [2,4]
    C0683954
    UMLS CUI [3]
    C0421228
    UMLS CUI [4]
    C0848067
    UMLS CUI [5]
    C0037431
    24. any condition that could jeopardize the safety of the patient or their compliance in the study
    Descrizione

    Condition At risk Patient safety | Condition At risk Protocol Compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C1113679
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C1444641
    UMLS CUI [2,3]
    C0525058

    Similar models

    Eligibility Hepatocellular Carcinoma NCT01217034

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. patients aged 20 years or over
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent
    Item
    2. patients who were fully informed of the study beforehand and signed the informed consent to participate in the study.
    boolean
    C0021430 (UMLS CUI [1])
    Life Expectancy
    Item
    3. patients who are expected to live more than 12 weeks.
    boolean
    C0023671 (UMLS CUI [1])
    Liver carcinoma Biopsy | Liver carcinoma Diagnostic Imaging | Liver carcinoma CT | Liver carcinoma MRI
    Item
    4. patients diagnosed with typical hcc by biopsy,cytology, or diagnostic imaging such as dynamic ct(mri).typical hcc is defined by aasld criteria.
    boolean
    C2239176 (UMLS CUI [1,1])
    C0005558 (UMLS CUI [1,2])
    C2239176 (UMLS CUI [2,1])
    C0011923 (UMLS CUI [2,2])
    C2239176 (UMLS CUI [3,1])
    C0040405 (UMLS CUI [3,2])
    C2239176 (UMLS CUI [4,1])
    C0024485 (UMLS CUI [4,2])
    Hepatectomy Unsuccessful | Radiofrequency ablation Unsuccessful
    Item
    5. patients in whom complete resection of the tumor by hepatectomy or complete tumor necrosis by local tumor necrosis therapy(rfa) cannot be expected to succeed.
    boolean
    C0019144 (UMLS CUI [1,1])
    C1272705 (UMLS CUI [1,2])
    C0850292 (UMLS CUI [2,1])
    C1272705 (UMLS CUI [2,2])
    Transarterial Chemoembolization Liver tumors | Tumor Diameter Maximum | Nodules Quantity Maximum
    Item
    6. patients with tumors which are confirmed to the liver and can be treated by tace(the maximum diameter equal to or less than 10cm,and the maximum number of nodule equal to or less than 10).
    boolean
    C3539919 (UMLS CUI [1,1])
    C0023903 (UMLS CUI [1,2])
    C0027651 (UMLS CUI [2,1])
    C1301886 (UMLS CUI [2,2])
    C0806909 (UMLS CUI [2,3])
    C0028259 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C0806909 (UMLS CUI [3,3])
    Target Lesion Measurable
    Item
    7. patients with viable and measurable target lesion.
    boolean
    C2986546 (UMLS CUI [1,1])
    C1513040 (UMLS CUI [1,2])
    Transarterial Chemoembolization Absent | Transarterial Chemoembolization Quantity
    Item
    8. patients with no or one history of tace therapy.
    boolean
    C3539919 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C3539919 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    ECOG performance status
    Item
    9. patients with an ecog ps(performance status) score of 0 or 1.
    boolean
    C1520224 (UMLS CUI [1])
    Child-Pugh Classification
    Item
    10. patients with child-pugh class a.
    boolean
    C4050412 (UMLS CUI [1])
    Laboratory Results Fulfill Criteria
    Item
    11. patients with laboratory values that meet the following criteria:
    boolean
    C1254595 (UMLS CUI [1,1])
    C1550543 (UMLS CUI [1,2])
    C0243161 (UMLS CUI [1,3])
    Hemoglobin measurement
    Item
    1. hemoglobin ≥ 8.5 g/dl
    boolean
    C0518015 (UMLS CUI [1])
    Granulocyte count
    Item
    2. granulocytes ≥ 1500/mm3
    boolean
    C0857490 (UMLS CUI [1])
    Platelet Count measurement
    Item
    3. platelet count ≥ 50,000 /mm3
    boolean
    C0032181 (UMLS CUI [1])
    Serum total bilirubin measurement
    Item
    4. total serum bilirubin ≤ 3 mg/dl
    boolean
    C1278039 (UMLS CUI [1])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement
    Item
    5. ast and alt ≤ 6 times upper limits of normal
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    Creatinine measurement, serum
    Item
    6. serum creatinine ≤ 1.5 times upper limits of normal
    boolean
    C0201976 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Malignant Neoplasms
    Item
    1. history of malignant tumor, excluding the following cases:
    boolean
    C0006826 (UMLS CUI [1])
    Exception Curative treatment Early stage cancer | Exception Low Risk Recurrent tumor | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Early gastric cancer
    Item
    1. curatively treated early stage cancer with a low risk of recurrence ,such as carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumor, and early gastric cancer.
    boolean
    C1705847 (UMLS CUI [1,1])
    C1273390 (UMLS CUI [1,2])
    C1517886 (UMLS CUI [1,3])
    C1705847 (UMLS CUI [2,1])
    C3538919 (UMLS CUI [2,2])
    C0521158 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0851140 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0007117 (UMLS CUI [4,2])
    C1705847 (UMLS CUI [5,1])
    C1336527 (UMLS CUI [5,2])
    C1705847 (UMLS CUI [6,1])
    C0349530 (UMLS CUI [6,2])
    Exception Curative treatment Malignant Neoplasm | Exception Recurrent tumor Absent
    Item
    2. malignant tumor that was curatively treated more than 3 years prior to study entry and has not recurred since then
    boolean
    C1705847 (UMLS CUI [1,1])
    C1273390 (UMLS CUI [1,2])
    C0006826 (UMLS CUI [1,3])
    C1705847 (UMLS CUI [2,1])
    C0521158 (UMLS CUI [2,2])
    C0332197 (UMLS CUI [2,3])
    Heart Disease | Criteria Any Fulfill
    Item
    2. cardiac disease that meet any of the following criteria:
    boolean
    C0018799 (UMLS CUI [1])
    C0243161 (UMLS CUI [2,1])
    C1552551 (UMLS CUI [2,2])
    C1550543 (UMLS CUI [2,3])
    Congestive heart failure New York Heart Association Classification
    Item
    1. nyha class iii or higher congestive heart failure
    boolean
    C0018802 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
    Coronary Artery Disease Symptomatic | Myocardial Infarction
    Item
    2. history of symptomatic coronary artery disease or myocardial infarction within 6 months before enrollment
    boolean
    C1956346 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0027051 (UMLS CUI [2])
    Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists Required | Digoxin Required
    Item
    3. arrhythmia requiring control by antiarrhythmic drugs such as beta-blockers or digoxin
    boolean
    C0003811 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0003195 (UMLS CUI [1,3])
    C0304516 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0012265 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    Communicable Disease Serious | Exception Hepatitis B | Exception Hepatitis C
    Item
    3. serious and active infection, except for hbv and hcv
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0019163 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0019196 (UMLS CUI [3,2])
    HIV Infection
    Item
    4. history of hiv infection
    boolean
    C0019693 (UMLS CUI [1])
    Hemodialysis
    Item
    5. renal dialysis
    boolean
    C0019004 (UMLS CUI [1])
    Tumor Diffuse Lesion
    Item
    6. diffuse tumor lesion
    boolean
    C0027651 (UMLS CUI [1,1])
    C1707743 (UMLS CUI [1,2])
    Neoplasm Metastasis Extrahepatic
    Item
    7. extrahepatic metastasis
    boolean
    C0027627 (UMLS CUI [1,1])
    C1517058 (UMLS CUI [1,2])
    Vascular Invasion
    Item
    8. vascular invasion
    boolean
    C0521157 (UMLS CUI [1])
    Neoplasms, Intracranial
    Item
    9. intracranial tumor
    boolean
    C1527390 (UMLS CUI [1])
    Hepatic Encephalopathy Pre-existing | Hepatic Encephalopathy
    Item
    10. preexisting or history of hepatic encephalopathy
    boolean
    C0019151 (UMLS CUI [1,1])
    C2347662 (UMLS CUI [1,2])
    C0019151 (UMLS CUI [2])
    Ascites Uncontrolled | Pleural effusion Uncontrolled
    Item
    11. clinically uncontrolled ascites or pleural effusion
    boolean
    C0003962 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0032227 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    Gastrointestinal Hemorrhage Severe
    Item
    12. clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
    boolean
    C0017181 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Esophageal Varices | Gastric Varices | High risk of bleeding
    Item
    13. esophageal and/or gastric varices which has high risk of bleeding
    boolean
    C0014867 (UMLS CUI [1])
    C0017145 (UMLS CUI [2])
    C4039184 (UMLS CUI [3])
    Thrombosis | Embolism
    Item
    14. history of thrombosis and/or embolism within 6 months of the start of treatment
    boolean
    C0040053 (UMLS CUI [1])
    C0013922 (UMLS CUI [2])
    Therapy Specified Any
    Item
    15. history of receiving any of the following therapies:
    boolean
    C0087111 (UMLS CUI [1,1])
    C0205369 (UMLS CUI [1,2])
    C1552551 (UMLS CUI [1,3])
    Systemic Chemotherapy Advanced Adult Hepatocellular Carcinoma | sorafenib
    Item
    1. systemic chemotherapy for advanced hcc(including sorafenib therapy)
    boolean
    C1883256 (UMLS CUI [1,1])
    C1706732 (UMLS CUI [1,2])
    C1516119 (UMLS CUI [2])
    Local Therapy | Radiofrequency ablation | Transarterial Chemoembolization | Hepatic arterial infusion
    Item
    2. local therapy, such as radiofrequency ablation, tace, or hepatic arterial infusion within 3 months of the start of treatment
    boolean
    C1517925 (UMLS CUI [1])
    C0850292 (UMLS CUI [2])
    C3539919 (UMLS CUI [3])
    C1134564 (UMLS CUI [4])
    CYP3A4 Inducers
    Item
    3. current treatment with cyp3a4 inducing agents
    boolean
    C3850041 (UMLS CUI [1])
    Surgery invasive
    Item
    4. invasive surgery within 4 weeks of the start of treatment
    boolean
    C0543467 (UMLS CUI [1,1])
    C0348025 (UMLS CUI [1,2])
    Transplantation, Homologous
    Item
    5. history of allogenic transplantation
    boolean
    C0040739 (UMLS CUI [1])
    Bone Marrow Transplantation | Hemopoietic stem cell transplant
    Item
    6. history of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study
    boolean
    C0005961 (UMLS CUI [1])
    C0472699 (UMLS CUI [2])
    Lacking Able to swallow Oral medication
    Item
    16. unable to take oral medications
    boolean
    C0332268 (UMLS CUI [1,1])
    C2712086 (UMLS CUI [1,2])
    C0175795 (UMLS CUI [1,3])
    Gastrointestinal problem Affecting Absorption Investigational New Drugs | Gastrointestinal problem Affecting Pharmacokinetics Investigational New Drugs
    Item
    17. gastrointestinal problems that may affect absorption or pharmacokinetics of the study drugs
    boolean
    C0017187 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0237442 (UMLS CUI [1,3])
    C0013230 (UMLS CUI [1,4])
    C0017187 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0031327 (UMLS CUI [2,3])
    C0013230 (UMLS CUI [2,4])
    Drugs Affecting Absorption Investigational New Drugs | Drugs Affecting Pharmacokinetics Investigational New Drugs
    Item
    18. use of drugs that may affect absorption or pharmacokinetics of the study drugs
    boolean
    C0013227 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0237442 (UMLS CUI [1,3])
    C0013230 (UMLS CUI [1,4])
    C0013227 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0031327 (UMLS CUI [2,3])
    C0013230 (UMLS CUI [2,4])
    Comorbidity Affecting Evaluation Investigational New Drugs
    Item
    19. concurrent disease or disability that may affect evaluation of the effects of the study drugs
    boolean
    C0009488 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C1261322 (UMLS CUI [1,3])
    C0013230 (UMLS CUI [1,4])
    Study Subject Participation Status | Clinical Trial
    Item
    20. enrollment in another study within 4 weeks of study entry
    boolean
    C2348568 (UMLS CUI [1])
    C0008976 (UMLS CUI [2])
    Pregnancy | Breast Feeding | Possible pregnancy | Pregnancy, Planned
    Item
    21. female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0425965 (UMLS CUI [3])
    C0032992 (UMLS CUI [4])
    Risk Allergic Reaction Investigational New Drugs
    Item
    22. risk of allergic reactions to the study drugs
    boolean
    C0035647 (UMLS CUI [1,1])
    C1527304 (UMLS CUI [1,2])
    C0013230 (UMLS CUI [1,3])
    Drug abuse Interferes with Study Subject Participation Status | Drug abuse Interferes with Evaluation Research results | Physical handicap problem | Mental problem | Social Problem
    Item
    23. drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
    boolean
    C0013146 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    C0013146 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C1261322 (UMLS CUI [2,3])
    C0683954 (UMLS CUI [2,4])
    C0421228 (UMLS CUI [3])
    C0848067 (UMLS CUI [4])
    C0037431 (UMLS CUI [5])
    Condition At risk Patient safety | Condition At risk Protocol Compliance
    Item
    24. any condition that could jeopardize the safety of the patient or their compliance in the study
    boolean
    C0348080 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C1113679 (UMLS CUI [1,3])
    C0348080 (UMLS CUI [2,1])
    C1444641 (UMLS CUI [2,2])
    C0525058 (UMLS CUI [2,3])

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