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])
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])