ID

39814

Beschrijving

Sorafenib Chemoembolization Evaluation Controlled Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01906216

Link

https://clinicaltrials.gov/show/NCT01906216

Trefwoorden

Versies (2)
  1. 22-02-20 22-02-20 -
  2. 27-09-21 27-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 februari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01906216

Engels

Eligibility Hepatocellular Carcinoma NCT01906216

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. prior informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. advanced stage hcc/ barcelona clinic liver cancer(bclc) c stage
Beschrijving

Liver carcinoma Advanced BCLC Stage

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3899974
3. confirmed diagnosis of hcc:
Beschrijving

Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
1. cirrhotic subjects: clinical diagnosis by asian pacific association for the study of the liver(aasld) criteria.
Beschrijving

Study Subject Cirrhotic | Clinical Diagnosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0439686
UMLS CUI [2]
C0332140
2. non-cirrhotic subjects: for subjects without cirrhosis, histological or cytological confirmation is mandatory
Beschrijving

Study Subject Without Liver Cirrhosis | Confirmation Histological | Confirmation Cytological

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0023890
UMLS CUI [2,1]
C0750484
UMLS CUI [2,2]
C0205462
UMLS CUI [3,1]
C0750484
UMLS CUI [3,2]
C0205471
3. documentation of original biopsy for diagnosis is acceptable
Beschrijving

Biopsy Diagnosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0011900
4. child pugh class a without ascites or hepatic encephalopathy
Beschrijving

Child-Pugh Classification | Ascites Absent | Hepatic Encephalopathy Absent

Datatype

boolean

Alias
UMLS CUI [1]
C2347612
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0019151
UMLS CUI [3,2]
C0332197
5. eastern cooperative oncology group(ecog) performance status of 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
6. at least one uni-dimensional lesion measurable by ct-scan or mri according to the recist, mrecist and easl criteria,respectively
Beschrijving

Measurable lesion Linear Quantity CT | Measurable lesion Linear Quantity MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0205132
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0024485
1. single lesion>5cm
Beschrijving

Single lesion Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0577304
UMLS CUI [1,2]
C0456389
2. 2-3 lesions, at least one lesion>3cm if more than 4 lesions, no limitation of the tumor size, but the sum of size of all tumor lesions should be less than 50% of liver parenchyma.
Beschrijving

Lesion Quantity | Lesion Quantity Lesion size | Sum Lesion size Percentage Liver parenchyma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0449453
UMLS CUI [3,1]
C1515051
UMLS CUI [3,2]
C0449453
UMLS CUI [3,3]
C0439165
UMLS CUI [3,4]
C0736268
7. male or female subjects ≥ 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
8. ability to swallow oral medications
Beschrijving

Able to swallow Oral medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
9. life expectancy of at least 12 weeks
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
10. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
Beschrijving

Gender Barrier Contraception

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
11. adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
Beschrijving

Bone Marrow function | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
1. hemoglobin > 9.0 g/dl
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
2. absolute neutrophil count (anc) >1,500/mm3
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
3. platelet count≥50x109/l
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
4. alb≥28g/l
Beschrijving

Albumin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201838
5. total bilirubin < 2 mg/dl
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
6. alanine aminotransferase(alt) and aspartate aminotransferase(ast) < 5 x upper limit of normal
Beschrijving

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
7. blood urea nitrogen(bun) and creatinine < 1.5 x upper limit of normal
Beschrijving

Blood urea nitrogen measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0005845
UMLS CUI [2]
C0201976
8. international normalized ratio(inr) < 1.7, or prothrombin time（pt） < 4 seconds above control
Beschrijving

International Normalized Ratio | Prothrombin time assay

Datatype

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0033707
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. diffuse hcc or tumor burden ≥50% of liver parenchyma
Beschrijving

Liver carcinoma Diffuse | Tumor Burden Percentage Liver parenchyma

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205219
UMLS CUI [2,1]
C1449699
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0736268
2. main portal vein obstruction, vascular invasion in hepatic vein or inferior vena cava
Beschrijving

Main portal vein Obstruction | Vascular Invasion Hepatic vein | Vascular Invasion Inferior vena cava

Datatype

boolean

Alias
UMLS CUI [1,1]
C1183135
UMLS CUI [1,2]
C0028778
UMLS CUI [2,1]
C0521157
UMLS CUI [2,2]
C0019155
UMLS CUI [3,1]
C0521157
UMLS CUI [3,2]
C0042458
3. presence of metastasis in biliary tract,brain or bone
Beschrijving

Metastasis Biliary tract | Metastatic malignant neoplasm to brain | Secondary malignant neoplasm of bone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0005423
UMLS CUI [2]
C0220650
UMLS CUI [3]
C0153690
4. poor blood supply for the liver tumor lesions; poor blood supply refers that the tumor lesions fail to show obvious contrast uptake in the arterial phase and washout in venous or late phases by ct scan or mri
Beschrijving

Blood supply Poor Liver tumor Lesion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005839
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0023903
UMLS CUI [1,4]
C0221198
5. any contraindications for hepatic embolization procedures:
Beschrijving

Medical contraindication Hepatic embolisation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0744813
1. known hepatofugal blood flow
Beschrijving

Hepatofugal flow

Datatype

boolean

Alias
UMLS CUI [1]
C4086746
2. known porto-systemic shunt
Beschrijving

Portosystemic shunt

Datatype

boolean

Alias
UMLS CUI [1]
C0948900
3. renal failure / insufficiency requiring hemo-or peritoneal dialysis
Beschrijving

Kidney Failure Requirement Hemodialysis | Renal Insufficiency Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis | Renal Insufficiency Requirement Peritoneal Dialysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019004
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0019004
UMLS CUI [3,1]
C0035078
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0031139
UMLS CUI [4,1]
C1565489
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0031139
6. target lesions having previously been treated with local therapy such as resection of hcc, radiofrequency ablation (rfa), percutaneous ethanol injection (pei)
Beschrijving

Liver carcinoma Excision | Radiofrequency ablation | Percutaneous ethanol injection

Datatype

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0728940
UMLS CUI [2]
C0850292
UMLS CUI [3]
C1880568
7. other molecular target drugs ongoing or completed < 4 weeks prior to the baseline scan
Beschrijving

Molecular Targeted Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C2699893
8. prior transarterial embolization or systemic chemotherapy
Beschrijving

Transarterial embolization | Systemic Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C3163695
UMLS CUI [2]
C1883256
9. any ≥ ctc adverse events(aes) grade 2 acute toxic effects of any prior local treatment
Beschrijving

CTCAE Grades | Toxic effects Due to Local Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1516728
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1517925
10. patients with untreated varices or active bleeding
Beschrijving

Varices untreated | Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042345
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0019080
11. history of cardiac disease:
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
1. congestive heart failure >new york heart association (nyha) class 2
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
2. uncontrolled hypertension
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
12. known history of hiv infection
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
13. active clinically serious infections (> grade 2 nci-ctcae version 3.0), except for hepatitis b virus(hbv) and hepatitis c virus(hcv) infection
Beschrijving

Communicable Diseases Serious CTCAE Grades | Exception Hepatitis B | Exception Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019163
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019196
14. clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
Beschrijving

Gastrointestinal Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0017181
15. thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug
Beschrijving

Thrombosis | Embolism | Cerebrovascular accident | Transient Ischemic Attack | Deep Vein Thrombosis | Pulmonary Embolism

Datatype

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C0013922
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
UMLS CUI [5]
C0149871
UMLS CUI [6]
C0034065
16. previous or concurrent cancer that is distinct in primary site or histology from hcc. any cancer curatively treated >3 years prior to entry is permitted
Beschrijving

Malignant Neoplasm Except Liver carcinoma | Exception Curative treatment Malignant Neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0006826
17. any contraindication for sorafenib or doxorubicin administration
Beschrijving

Medical contraindication Sorafenib | Medical contraindication Doxorubicin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1516119
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013089
18. pregnant or breast-feeding subjects
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
19. any disease(within 6 months of randomization)which could affect the evaluation of the study drug
Beschrijving

Disease Affecting Evaluation Investigational New Drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0013230
20. any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
Beschrijving

Patient's condition unstable | Condition At risk Patient safety | Condition At risk Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0438114
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0525058
21. major surgery within 4 weeks prior to start of study drug (e.g. thoracolaparotomy is not allowed, but noninvasive surgery, e.g. biopsy, is allowed)
Beschrijving

Major surgery | Thoracotomy Laparotomy Combined

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0039991
UMLS CUI [2,2]
C0023038
UMLS CUI [2,3]
C0205195
22. autologous bone marrow transplant or stem cell rescue within 1 year prior to start of study drug
Beschrijving

Autologous bone marrow transplant | Autologous Stem Cell Rescue

Datatype

boolean

Alias
UMLS CUI [1]
C0194037
UMLS CUI [2]
C2825926
23. history of organ allograft
Beschrijving

Organ allograft

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0040739
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Similar models

Eligibility Hepatocellular Carcinoma NCT01906216

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. prior informed consent
boolean
C0021430 (UMLS CUI [1])
Liver carcinoma Advanced BCLC Stage
Item
2. advanced stage hcc/ barcelona clinic liver cancer(bclc) c stage
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3899974 (UMLS CUI [1,3])
Liver carcinoma
Item
3. confirmed diagnosis of hcc:
boolean
C2239176 (UMLS CUI [1])
Study Subject Cirrhotic | Clinical Diagnosis
Item
1. cirrhotic subjects: clinical diagnosis by asian pacific association for the study of the liver(aasld) criteria.
boolean
C0681850 (UMLS CUI [1,1])
C0439686 (UMLS CUI [1,2])
C0332140 (UMLS CUI [2])
Study Subject Without Liver Cirrhosis | Confirmation Histological | Confirmation Cytological
Item
2. non-cirrhotic subjects: for subjects without cirrhosis, histological or cytological confirmation is mandatory
boolean
C0681850 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0023890 (UMLS CUI [1,3])
C0750484 (UMLS CUI [2,1])
C0205462 (UMLS CUI [2,2])
C0750484 (UMLS CUI [3,1])
C0205471 (UMLS CUI [3,2])
Biopsy Diagnosis
Item
3. documentation of original biopsy for diagnosis is acceptable
boolean
C0005558 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Child-Pugh Classification | Ascites Absent | Hepatic Encephalopathy Absent
Item
4. child pugh class a without ascites or hepatic encephalopathy
boolean
C2347612 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019151 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
ECOG performance status
Item
5. eastern cooperative oncology group(ecog) performance status of 0-1
boolean
C1520224 (UMLS CUI [1])
Measurable lesion Linear Quantity CT | Measurable lesion Linear Quantity MRI
Item
6. at least one uni-dimensional lesion measurable by ct-scan or mri according to the recist, mrecist and easl criteria,respectively
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,4])
C1513041 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
Single lesion Size
Item
1. single lesion>5cm
boolean
C0577304 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Lesion Quantity | Lesion Quantity Lesion size | Sum Lesion size Percentage Liver parenchyma
Item
2. 2-3 lesions, at least one lesion>3cm if more than 4 lesions, no limitation of the tumor size, but the sum of size of all tumor lesions should be less than 50% of liver parenchyma.
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0449453 (UMLS CUI [2,3])
C1515051 (UMLS CUI [3,1])
C0449453 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
C0736268 (UMLS CUI [3,4])
Age
Item
7. male or female subjects ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Able to swallow Oral medication
Item
8. ability to swallow oral medications
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Life Expectancy
Item
9. life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Gender Barrier Contraception
Item
10. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
Bone Marrow function | Liver function | Renal function
Item
11. adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Hemoglobin measurement
Item
1. hemoglobin > 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
2. absolute neutrophil count (anc) >1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelet count≥50x109/l
boolean
C0032181 (UMLS CUI [1])
Albumin measurement
Item
4. alb≥28g/l
boolean
C0201838 (UMLS CUI [1])
Serum total bilirubin measurement
Item
5. total bilirubin < 2 mg/dl
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
6. alanine aminotransferase(alt) and aspartate aminotransferase(ast) < 5 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Blood urea nitrogen measurement | Creatinine measurement, serum
Item
7. blood urea nitrogen(bun) and creatinine < 1.5 x upper limit of normal
boolean
C0005845 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
International Normalized Ratio | Prothrombin time assay
Item
8. international normalized ratio(inr) < 1.7, or prothrombin time（pt） < 4 seconds above control
boolean
C0525032 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Liver carcinoma Diffuse | Tumor Burden Percentage Liver parenchyma
Item
1. diffuse hcc or tumor burden ≥50% of liver parenchyma
boolean
C2239176 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C1449699 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0736268 (UMLS CUI [2,3])
Main portal vein Obstruction | Vascular Invasion Hepatic vein | Vascular Invasion Inferior vena cava
Item
2. main portal vein obstruction, vascular invasion in hepatic vein or inferior vena cava
boolean
C1183135 (UMLS CUI [1,1])
C0028778 (UMLS CUI [1,2])
C0521157 (UMLS CUI [2,1])
C0019155 (UMLS CUI [2,2])
C0521157 (UMLS CUI [3,1])
C0042458 (UMLS CUI [3,2])
Metastasis Biliary tract | Metastatic malignant neoplasm to brain | Secondary malignant neoplasm of bone
Item
3. presence of metastasis in biliary tract,brain or bone
boolean
C0027627 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
C0153690 (UMLS CUI [3])
Blood supply Poor Liver tumor Lesion
Item
4. poor blood supply for the liver tumor lesions; poor blood supply refers that the tumor lesions fail to show obvious contrast uptake in the arterial phase and washout in venous or late phases by ct scan or mri
boolean
C0005839 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0023903 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,4])
Medical contraindication Hepatic embolisation
Item
5. any contraindications for hepatic embolization procedures:
boolean
C1301624 (UMLS CUI [1,1])
C0744813 (UMLS CUI [1,2])
Hepatofugal flow
Item
1. known hepatofugal blood flow
boolean
C4086746 (UMLS CUI [1])
Portosystemic shunt
Item
2. known porto-systemic shunt
boolean
C0948900 (UMLS CUI [1])
Kidney Failure Requirement Hemodialysis | Renal Insufficiency Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis | Renal Insufficiency Requirement Peritoneal Dialysis
Item
3. renal failure / insufficiency requiring hemo-or peritoneal dialysis
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
C1565489 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0019004 (UMLS CUI [2,3])
C0035078 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0031139 (UMLS CUI [3,3])
C1565489 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0031139 (UMLS CUI [4,3])
Liver carcinoma Excision | Radiofrequency ablation | Percutaneous ethanol injection
Item
6. target lesions having previously been treated with local therapy such as resection of hcc, radiofrequency ablation (rfa), percutaneous ethanol injection (pei)
boolean
C2239176 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0850292 (UMLS CUI [2])
C1880568 (UMLS CUI [3])
Molecular Targeted Therapy
Item
7. other molecular target drugs ongoing or completed < 4 weeks prior to the baseline scan
boolean
C2699893 (UMLS CUI [1])
Transarterial embolization | Systemic Chemotherapy
Item
8. prior transarterial embolization or systemic chemotherapy
boolean
C3163695 (UMLS CUI [1])
C1883256 (UMLS CUI [2])
CTCAE Grades | Toxic effects Due to Local Therapy
Item
9. any ≥ ctc adverse events(aes) grade 2 acute toxic effects of any prior local treatment
boolean
C1516728 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1517925 (UMLS CUI [2,3])
Varices untreated | Hemorrhage
Item
10. patients with untreated varices or active bleeding
boolean
C0042345 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2])
Heart Disease
Item
11. history of cardiac disease:
boolean
C0018799 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
1. congestive heart failure >new york heart association (nyha) class 2
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Uncontrolled hypertension
Item
2. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
HIV Infection
Item
12. known history of hiv infection
boolean
C0019693 (UMLS CUI [1])
Communicable Diseases Serious CTCAE Grades | Exception Hepatitis B | Exception Hepatitis C
Item
13. active clinically serious infections (> grade 2 nci-ctcae version 3.0), except for hepatitis b virus(hbv) and hepatitis c virus(hcv) infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
Gastrointestinal Hemorrhage
Item
14. clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
boolean
C0017181 (UMLS CUI [1])
Thrombosis | Embolism | Cerebrovascular accident | Transient Ischemic Attack | Deep Vein Thrombosis | Pulmonary Embolism
Item
15. thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug
boolean
C0040053 (UMLS CUI [1])
C0013922 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0149871 (UMLS CUI [5])
C0034065 (UMLS CUI [6])
Malignant Neoplasm Except Liver carcinoma | Exception Curative treatment Malignant Neoplasm
Item
16. previous or concurrent cancer that is distinct in primary site or histology from hcc. any cancer curatively treated >3 years prior to entry is permitted
boolean
C0006826 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Medical contraindication Sorafenib | Medical contraindication Doxorubicin
Item
17. any contraindication for sorafenib or doxorubicin administration
boolean
C1301624 (UMLS CUI [1,1])
C1516119 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013089 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
18. pregnant or breast-feeding subjects
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Affecting Evaluation Investigational New Drug
Item
19. any disease(within 6 months of randomization)which could affect the evaluation of the study drug
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Patient's condition unstable | Condition At risk Patient safety | Condition At risk Protocol Compliance
Item
20. any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
boolean
C0438114 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Major surgery | Thoracotomy Laparotomy Combined
Item
21. major surgery within 4 weeks prior to start of study drug (e.g. thoracolaparotomy is not allowed, but noninvasive surgery, e.g. biopsy, is allowed)
boolean
C0679637 (UMLS CUI [1])
C0039991 (UMLS CUI [2,1])
C0023038 (UMLS CUI [2,2])
C0205195 (UMLS CUI [2,3])
Autologous bone marrow transplant | Autologous Stem Cell Rescue
Item
22. autologous bone marrow transplant or stem cell rescue within 1 year prior to start of study drug
boolean
C0194037 (UMLS CUI [1])
C2825926 (UMLS CUI [2])
Organ allograft
Item
23. history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
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