ID

29807

Description

4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00943449

Link

https://clinicaltrials.gov/show/NCT00943449

Keywords

Versions (2)
  1. 4/20/18 4/20/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00943449

English

Eligibility Hepatocellular Carcinoma NCT00943449

1 forms  
Criteria
Description

Criteria

advanced stage hepatocellular carcinoma
Description

Liver carcinoma Advanced phase

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
patients exhibiting progressive disease under sorafenib treatment
Description

Progressive Disease | Sorafenib

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C1516119
child-pugh class a and b. only patients with child-pugh index class b of not more than 7 will be included
Description

Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1]
C2347612
ecog performance status 0, 1 or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
precedent first-line treatment with sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks
Description

First line treatment Sorafenib Dosage U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1516119
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0456683
main exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
previous or concurrent cancer that is distinct in primary site or histology from hcc, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta, tis and t1) - any cancer curatively treated > 3 years prior to entry is permitted
Description

Cancer Other Different Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Bladder Neoplasm Superficial TNM clinical staging | Curative treatment Neoplasm allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C1705242
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0005695
UMLS CUI [4,3]
C0205124
UMLS CUI [4,4]
C3258246
UMLS CUI [5,1]
C1273390
UMLS CUI [5,2]
C0027651
UMLS CUI [5,3]
C0683607
renal failure requiring hemo- or peritoneal dialysis
Description

Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019004
UMLS CUI [2,1]
C0035078
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0031139
known central nervous system (cns) tumors including symptomatic brain metastasis
Description

Central Nervous System Neoplasms | Metastatic malignant neoplasm to brain Symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0085136
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
child-pugh index class b in combination with more than slight ascites or hepatic encephalopathy > grade i
Description

Child-Pugh Classification | Ascites Grade | Hepatic Encephalopathy Grade

Data type

boolean

Alias
UMLS CUI [1]
C2347612
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0441800
UMLS CUI [3,1]
C0019151
UMLS CUI [3,2]
C0441800
pregnant or breastfeeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
sorafenib intolerance
Description

Intolerance to Sorafenib

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1516119
major surgery within the last 4 weeks
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Hepatocellular Carcinoma NCT00943449

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Liver carcinoma Advanced phase
Item
advanced stage hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Progressive Disease | Sorafenib
Item
patients exhibiting progressive disease under sorafenib treatment
boolean
C1335499 (UMLS CUI [1])
C1516119 (UMLS CUI [2])
Child-Pugh Classification
Item
child-pugh class a and b. only patients with child-pugh index class b of not more than 7 will be included
boolean
C2347612 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
First line treatment Sorafenib Dosage U/day
Item
precedent first-line treatment with sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks
boolean
C1708063 (UMLS CUI [1,1])
C1516119 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Cancer Other Different Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Bladder Neoplasm Superficial TNM clinical staging | Curative treatment Neoplasm allowed
Item
previous or concurrent cancer that is distinct in primary site or histology from hcc, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta, tis and t1) - any cancer curatively treated > 3 years prior to entry is permitted
boolean
C1707251 (UMLS CUI [1,1])
C1705242 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0005695 (UMLS CUI [4,2])
C0205124 (UMLS CUI [4,3])
C3258246 (UMLS CUI [4,4])
C1273390 (UMLS CUI [5,1])
C0027651 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis
Item
renal failure requiring hemo- or peritoneal dialysis
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
C0035078 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0031139 (UMLS CUI [2,3])
Central Nervous System Neoplasms | Metastatic malignant neoplasm to brain Symptomatic
Item
known central nervous system (cns) tumors including symptomatic brain metastasis
boolean
C0085136 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Child-Pugh Classification | Ascites Grade | Hepatic Encephalopathy Grade
Item
child-pugh index class b in combination with more than slight ascites or hepatic encephalopathy > grade i
boolean
C2347612 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0019151 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Intolerance to Sorafenib
Item
sorafenib intolerance
boolean
C1744706 (UMLS CUI [1,1])
C1516119 (UMLS CUI [1,2])
Major surgery
Item
major surgery within the last 4 weeks
boolean
C0679637 (UMLS CUI [1])
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