ID

44415

Description

Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Advanced Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00703365

Link

https://clinicaltrials.gov/show/NCT00703365

Keywords

Versions (2)
  1. 11/12/17 11/12/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT00703365

English

Eligibility Carcinoma, Hepatocellular NCT00703365

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient at least 18 years of age with written informed consent prior to enrollment into the study.
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
histologically or cytologically confirmed advanced unresectable and/or metastasis) hcc
Description

Advanced Adult Hepatocellular Carcinoma unresectable | Metastatic hepatocellular carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1706732
UMLS CUI [1,2]
C1519810
UMLS CUI [2]
C0744869
child-pugh class a or b
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C4050412
have measurable disease according to recist criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
life expectancy of at least 12 weeks, ecog 0-2
Description

Life Expectancy | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C1520224
have adequate bone marrow reserve and liver and renal function at screening
Description

Bone Marrow Mature Neutrophils Present Complete | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
practice adequate contraception during study participation
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclude medical conditions including history of cardiac disease, hiv infection,active infection,brain metastastasis or intracranial metastasis,seizure disorder requiring medication, history of organ allograft,evidence of or history of bleeding diathesis,previous or concurrent cancer with distinct in primary site or histology (with exception of cervical carcinoma in situ and treated basal cell carcinoma
Description

Heart Diseases | HIV Infection | Communicable Disease | Metastatic malignant neoplasm to brain | Neoplasm Metastasis Intracranial | Epilepsy Requirement Pharmaceutical Preparations | Organ Allograft | Bleeding tendency | Primary tumor site Different | Malignant Neoplasm Histology Different | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0009450
UMLS CUI [4]
C0220650
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C0524466
UMLS CUI [6,1]
C0014544
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0013227
UMLS CUI [7,1]
C0178784
UMLS CUI [7,2]
C0040739
UMLS CUI [8]
C1458140
UMLS CUI [9,1]
C0475447
UMLS CUI [9,2]
C1705242
UMLS CUI [10,1]
C0006826
UMLS CUI [10,2]
C4048239
UMLS CUI [10,3]
C1705242
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0851140
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0007117
UMLS CUI [12,3]
C1522326
excluded therapies and medications, previous and concomitant : prior systemic anticancer chemotherapy or immunotherapy or targeted therapy,hormonal therapy within 2 weeks,local treatment modality within 4 weeks,radiotherapy within 3 weeks,major surgery and unhealed wound within 4 weeks,autologous bone marrow transplant or stem cell rescue within 4 months
Description

Systemic Chemotherapy Malignant Neoplasms | Immunotherapy | Targeted Therapy | Hormone Therapy | Local Therapy | Therapeutic radiology procedure | Major surgery | Wound, non-healed | Autologous bone marrow transplant | Autologous Stem Cell Rescue

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0021083
UMLS CUI [3]
C2985566
UMLS CUI [4]
C0279025
UMLS CUI [5]
C1517925
UMLS CUI [6]
C1522449
UMLS CUI [7]
C0679637
UMLS CUI [8]
C0750433
UMLS CUI [9]
C0194037
UMLS CUI [10]
C2825926
other condition that may interfere with the patient's participation in the study or evaluation of the results
Description

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
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Similar models

Eligibility Carcinoma, Hepatocellular NCT00703365

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
patient at least 18 years of age with written informed consent prior to enrollment into the study.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Advanced Adult Hepatocellular Carcinoma unresectable | Metastatic hepatocellular carcinoma
Item
histologically or cytologically confirmed advanced unresectable and/or metastasis) hcc
boolean
C1706732 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0744869 (UMLS CUI [2])
Child-Pugh Classification
Item
child-pugh class a or b
boolean
C4050412 (UMLS CUI [1])
Measurable Disease
Item
have measurable disease according to recist criteria
boolean
C1513041 (UMLS CUI [1])
Life Expectancy | ECOG performance status
Item
life expectancy of at least 12 weeks, ecog 0-2
boolean
C0023671 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Bone Marrow Mature Neutrophils Present Complete | Liver function | Renal function
Item
have adequate bone marrow reserve and liver and renal function at screening
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Contraceptive methods
Item
practice adequate contraception during study participation
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Diseases | HIV Infection | Communicable Disease | Metastatic malignant neoplasm to brain | Neoplasm Metastasis Intracranial | Epilepsy Requirement Pharmaceutical Preparations | Organ Allograft | Bleeding tendency | Primary tumor site Different | Malignant Neoplasm Histology Different | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated
Item
exclude medical conditions including history of cardiac disease, hiv infection,active infection,brain metastastasis or intracranial metastasis,seizure disorder requiring medication, history of organ allograft,evidence of or history of bleeding diathesis,previous or concurrent cancer with distinct in primary site or histology (with exception of cervical carcinoma in situ and treated basal cell carcinoma
boolean
C0018799 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C0220650 (UMLS CUI [4])
C0027627 (UMLS CUI [5,1])
C0524466 (UMLS CUI [5,2])
C0014544 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
C0178784 (UMLS CUI [7,1])
C0040739 (UMLS CUI [7,2])
C1458140 (UMLS CUI [8])
C0475447 (UMLS CUI [9,1])
C1705242 (UMLS CUI [9,2])
C0006826 (UMLS CUI [10,1])
C4048239 (UMLS CUI [10,2])
C1705242 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0851140 (UMLS CUI [11,2])
C1705847 (UMLS CUI [12,1])
C0007117 (UMLS CUI [12,2])
C1522326 (UMLS CUI [12,3])
Systemic Chemotherapy Malignant Neoplasms | Immunotherapy | Targeted Therapy | Hormone Therapy | Local Therapy | Therapeutic radiology procedure | Major surgery | Wound, non-healed | Autologous bone marrow transplant | Autologous Stem Cell Rescue
Item
excluded therapies and medications, previous and concomitant : prior systemic anticancer chemotherapy or immunotherapy or targeted therapy,hormonal therapy within 2 weeks,local treatment modality within 4 weeks,radiotherapy within 3 weeks,major surgery and unhealed wound within 4 weeks,autologous bone marrow transplant or stem cell rescue within 4 months
boolean
C1883256 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2])
C2985566 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C1517925 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
C0679637 (UMLS CUI [7])
C0750433 (UMLS CUI [8])
C0194037 (UMLS CUI [9])
C2825926 (UMLS CUI [10])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
other condition that may interfere with the patient's participation in the study or evaluation of the results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
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