ID

37426

Description

Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02006030

Link

https://clinicaltrials.gov/show/NCT02006030

Keywords

Versions (1)
  1. 7/25/19 7/25/19 -
Copyright Holder

See clinicaltrials.gov

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July 25, 2019

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License

Creative Commons BY 4.0
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Eligibility Unresectable Hepatocellular Carcinoma NCT02006030

English

Eligibility Unresectable Hepatocellular Carcinoma NCT02006030

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of hcc confirmed clinically or histologically or cytologically. a clinical diagnosis of hcc, using the 2010 guideline of the american association for the study of liver diseases requires the presence of hepatic tumor(s) with image findings (e.g. sonography, ct or mri) compatible with hcc, and no evidence of other gastrointestinal tumors (bruix [2011] - guideline, 2010).
Description

Liver carcinoma | Liver carcinoma Imaging finding | Ultrasonography compatible with Liver carcinoma | CT compatible with Liver carcinoma | MRI compatible with Liver carcinoma | Gastrointestinal Neoplasms Other Absent

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C1287399
UMLS CUI [3,1]
C0041618
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C2239176
UMLS CUI [4,1]
C0040405
UMLS CUI [4,2]
C0332290
UMLS CUI [4,3]
C2239176
UMLS CUI [5,1]
C0024485
UMLS CUI [5,2]
C0332290
UMLS CUI [5,3]
C2239176
UMLS CUI [6,1]
C0017185
UMLS CUI [6,2]
C0205394
UMLS CUI [6,3]
C0332197
2. solitary hepatic tumor <8 cm in diameter or multifocal disease as evidenced by ct or mri scan. tumor volume ≥50% of liver organ or infiltrating hcc should be excluded.
Description

Liver carcinoma Solitary Diameter CT scan | Disease Multifocal CT scan | Liver carcinoma Solitary Diameter MRI scan | Disease Multifocal MRI scan | Tumor Volume Percentage Excluded | Liver carcinoma Infiltrating Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205292
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0205171
UMLS CUI [3,3]
C1301886
UMLS CUI [3,4]
C0024485
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205292
UMLS CUI [4,3]
C0024485
UMLS CUI [5,1]
C0475276
UMLS CUI [5,2]
C0439165
UMLS CUI [5,3]
C0332196
UMLS CUI [6,1]
C2239176
UMLS CUI [6,2]
C0332448
UMLS CUI [6,3]
C0332196
3. not a candidate for surgical resection or ablation of the tumor.
Description

Patient Inappropriate Surgical resection | Patient InappropriateTumor Ablation

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0728940
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0027651
UMLS CUI [2,4]
C0547070
4. the target lesion must not have been treated previously with local therapy, including tace. prior local therapy (radiofrequency ablation, percutaneous ethanol injection, cryoablation, or surgery) to nontarget lesions is acceptable.
Description

Local Therapy Absent Target Lesion | Transarterial Chemoembolization Absent | Local Therapy Non-Target Lesion Acceptable | Radiofrequency ablation Non-Target Lesion Acceptable | Percutaneous ethanol injection therapy Non-Target Lesion Acceptable | Cryoablation Non-Target Lesion Acceptable | Operative Surgical Procedure Non-Target Lesion Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C2986546
UMLS CUI [2,1]
C3539919
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1517925
UMLS CUI [3,2]
C2986547
UMLS CUI [3,3]
C1879533
UMLS CUI [4,1]
C0850292
UMLS CUI [4,2]
C2986547
UMLS CUI [4,3]
C1879533
UMLS CUI [5,1]
C1535909
UMLS CUI [5,2]
C2986547
UMLS CUI [5,3]
C1879533
UMLS CUI [6,1]
C0010408
UMLS CUI [6,2]
C2986547
UMLS CUI [6,3]
C1879533
UMLS CUI [7,1]
C0543467
UMLS CUI [7,2]
C2986547
UMLS CUI [7,3]
C1879533
5. the subject must have received no more than 2 tace (n≤ 2) or the previous tace was performed longer than 2 months before enrollment.
Description

Transarterial Chemoembolization Quantity | Transarterial Chemoembolization Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C3539919
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3539919
UMLS CUI [2,2]
C0205156
6. local therapy must have been completed at least 4 weeks before baseline scan.
Description

Local Therapy Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0205197
7. measurable disease using mrecist criteria (appendix a) and recist1.1 (appendix b) criteria. at least 1 measurable lesion must be present.
Description

Measurable Disease | Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
8. barcelona clinic liver cancer (bclc) staging classification b (intermediate stage) (appendix c).
Description

Hepatocellular Carcinoma by BCLC Stage

Data type

boolean

Alias
UMLS CUI [1]
C3898888
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. 1. candidate for potential curative therapies (i.e., resection or transplantation).
Description

Patient Appropriate Curative treatment | Patient Appropriate Excision | Patient Appropriate Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1273390
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0728940
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0040732
2. prior allograft transplantation including liver transplantation.
Description

Transplantation, Homologous | Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1]
C0040739
UMLS CUI [2]
C0023911
3. significant cardiac disease (new york heart association class iii or iv; appendix f).
Description

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
4. serious infection requiring treatment with systemically administered antibiotics.
Description

Communicable Disease Serious | Requirement Antibiotics for systemic use

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C3540704
5. pregnancy or lactation.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. expected non-compliance.
Description

Compliance behavior Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0750558
7. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association class iii or iv), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0742758
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
8. subjects who have had any anticancer treatment within 2 weeks prior to week 1 visit.
Description

Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
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Similar models

Eligibility Unresectable Hepatocellular Carcinoma NCT02006030

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Liver carcinoma Imaging finding | Ultrasonography compatible with Liver carcinoma | CT compatible with Liver carcinoma | MRI compatible with Liver carcinoma | Gastrointestinal Neoplasms Other Absent
Item
1. diagnosis of hcc confirmed clinically or histologically or cytologically. a clinical diagnosis of hcc, using the 2010 guideline of the american association for the study of liver diseases requires the presence of hepatic tumor(s) with image findings (e.g. sonography, ct or mri) compatible with hcc, and no evidence of other gastrointestinal tumors (bruix [2011] - guideline, 2010).
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C1287399 (UMLS CUI [2,2])
C0041618 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C2239176 (UMLS CUI [3,3])
C0040405 (UMLS CUI [4,1])
C0332290 (UMLS CUI [4,2])
C2239176 (UMLS CUI [4,3])
C0024485 (UMLS CUI [5,1])
C0332290 (UMLS CUI [5,2])
C2239176 (UMLS CUI [5,3])
C0017185 (UMLS CUI [6,1])
C0205394 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Liver carcinoma Solitary Diameter CT scan | Disease Multifocal CT scan | Liver carcinoma Solitary Diameter MRI scan | Disease Multifocal MRI scan | Tumor Volume Percentage Excluded | Liver carcinoma Infiltrating Excluded
Item
2. solitary hepatic tumor <8 cm in diameter or multifocal disease as evidenced by ct or mri scan. tumor volume ≥50% of liver organ or infiltrating hcc should be excluded.
boolean
C2239176 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205292 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
C1301886 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0205292 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C0475276 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C0332196 (UMLS CUI [5,3])
C2239176 (UMLS CUI [6,1])
C0332448 (UMLS CUI [6,2])
C0332196 (UMLS CUI [6,3])
Patient Inappropriate Surgical resection | Patient InappropriateTumor Ablation
Item
3. not a candidate for surgical resection or ablation of the tumor.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
C0547070 (UMLS CUI [2,4])
Local Therapy Absent Target Lesion | Transarterial Chemoembolization Absent | Local Therapy Non-Target Lesion Acceptable | Radiofrequency ablation Non-Target Lesion Acceptable | Percutaneous ethanol injection therapy Non-Target Lesion Acceptable | Cryoablation Non-Target Lesion Acceptable | Operative Surgical Procedure Non-Target Lesion Acceptable
Item
4. the target lesion must not have been treated previously with local therapy, including tace. prior local therapy (radiofrequency ablation, percutaneous ethanol injection, cryoablation, or surgery) to nontarget lesions is acceptable.
boolean
C1517925 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C3539919 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1517925 (UMLS CUI [3,1])
C2986547 (UMLS CUI [3,2])
C1879533 (UMLS CUI [3,3])
C0850292 (UMLS CUI [4,1])
C2986547 (UMLS CUI [4,2])
C1879533 (UMLS CUI [4,3])
C1535909 (UMLS CUI [5,1])
C2986547 (UMLS CUI [5,2])
C1879533 (UMLS CUI [5,3])
C0010408 (UMLS CUI [6,1])
C2986547 (UMLS CUI [6,2])
C1879533 (UMLS CUI [6,3])
C0543467 (UMLS CUI [7,1])
C2986547 (UMLS CUI [7,2])
C1879533 (UMLS CUI [7,3])
Transarterial Chemoembolization Quantity | Transarterial Chemoembolization Previous
Item
5. the subject must have received no more than 2 tace (n≤ 2) or the previous tace was performed longer than 2 months before enrollment.
boolean
C3539919 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3539919 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Local Therapy Completed
Item
6. local therapy must have been completed at least 4 weeks before baseline scan.
boolean
C1517925 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Measurable Disease | Measurable lesion Quantity
Item
7. measurable disease using mrecist criteria (appendix a) and recist1.1 (appendix b) criteria. at least 1 measurable lesion must be present.
boolean
C1513041 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Hepatocellular Carcinoma by BCLC Stage
Item
8. barcelona clinic liver cancer (bclc) staging classification b (intermediate stage) (appendix c).
boolean
C3898888 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patient Appropriate Curative treatment | Patient Appropriate Excision | Patient Appropriate Transplantation
Item
1. 1. candidate for potential curative therapies (i.e., resection or transplantation).
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0040732 (UMLS CUI [3,3])
Transplantation, Homologous | Transplantation of liver
Item
2. prior allograft transplantation including liver transplantation.
boolean
C0040739 (UMLS CUI [1])
C0023911 (UMLS CUI [2])
Heart Disease New York Heart Association Classification
Item
3. significant cardiac disease (new york heart association class iii or iv; appendix f).
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Communicable Disease Serious | Requirement Antibiotics for systemic use
Item
4. serious infection requiring treatment with systemically administered antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C3540704 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
5. pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Compliance behavior Unlikely
Item
6. expected non-compliance.
boolean
C1321605 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
7. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association class iii or iv), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Cancer treatment
Item
8. subjects who have had any anticancer treatment within 2 weeks prior to week 1 visit.
boolean
C0920425 (UMLS CUI [1])
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