Liver carcinoma | Radiology Consistent with Liver carcinoma | Radiology Consistent with Alpha one fetoprotein measurement | Radiology Consistent with Liver Cirrhosis
Item
patients with histologically confirmed hepatocellular carcinoma (hcc) or a combination of radiologically compatible finding to hcc, alpha-fetoprotein > 400ng/ml and liver cirrhosis
boolean
C2239176 (UMLS CUI [1])
C0043299 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C0043299 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0201539 (UMLS CUI [3,3])
C0043299 (UMLS CUI [4,1])
C0332290 (UMLS CUI [4,2])
C0023890 (UMLS CUI [4,3])
Disease Inoperable | Disease Extrahepatic | Main portal vein Involvement | Main portal vein Invasion | Main portal vein Tumor Thrombus | Hepatic vein Involvement | Hepatic vein Invasion | Hepatic vein Tumor Thrombus | Liver carcinoma Inappropriate Therapeutic procedure Intraarterial | Liver carcinoma Inappropriate Ablation
Item
inoperable disease as defined by (localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin or presence of extra-hepatic disease or main portal vein or hepatic vein involvement (invasion or tumor thrombus) or the hcc must not be amenable to intra-arterial therapy or local ablative therapy)
boolean
C0012634 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1517058 (UMLS CUI [2,2])
C1183135 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C1183135 (UMLS CUI [4,1])
C1269955 (UMLS CUI [4,2])
C1183135 (UMLS CUI [5,1])
C0027651 (UMLS CUI [5,2])
C0087086 (UMLS CUI [5,3])
C0019155 (UMLS CUI [6,1])
C1314939 (UMLS CUI [6,2])
C0019155 (UMLS CUI [7,1])
C1269955 (UMLS CUI [7,2])
C0019155 (UMLS CUI [8,1])
C0027651 (UMLS CUI [8,2])
C0087086 (UMLS CUI [8,3])
C2239176 (UMLS CUI [9,1])
C1548788 (UMLS CUI [9,2])
C0087111 (UMLS CUI [9,3])
C0694634 (UMLS CUI [9,4])
C2239176 (UMLS CUI [10,1])
C1548788 (UMLS CUI [10,2])
C0547070 (UMLS CUI [10,3])
Life Expectancy
Item
minimum life expectancy of 12 weeks
boolean
C0023671 (UMLS CUI [1])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of ≤ 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Albumin measurement | Prothrombin time international normalized ratio (PT-INR) | Activated Partial Thromboplastin Time measurement | Creatinine measurement, serum | Creatinine clearance measurement
Item
(hemoglobin > 9.0 g/dl,absolute neutrophil count>1,500/mm3, platelet count>75,000/μl,total bilirubin < 1.5 times the upper limit of normal,alt and ast < 5 x upper limit of normal,albumin ≥ 3g/dl,pt-inr/ptt < 1.5 x upper limit of normal,serum creatinine < 1.5 x upper limit of normal or creatinine clearance ≥ 50ml/min)
boolean
C0518015 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201838 (UMLS CUI [7])
C1821762 (UMLS CUI [8])
C0030605 (UMLS CUI [9])
C0201976 (UMLS CUI [10])
C0373595 (UMLS CUI [11])
Informed Consent
Item
signed and dated informed consent before the start of specific protocol procedures.
boolean
C0021430 (UMLS CUI [1])
Fine needle aspiration biopsy
Item
fna will be performed in patients with feasible biopsy site
boolean
C1510483 (UMLS CUI [1])
Decompensated cirrhosis | Child-Pugh Classification
Item
decompensated cirrhosis or stage c (index > 10) according to the child-pugh classification
boolean
C1619727 (UMLS CUI [1])
C2347612 (UMLS CUI [2])
Antineoplastic Agents | Tamoxifen | Interferon
Item
other concomitant anticancer agent, including tamoxifen and interferon
boolean
C0003392 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
C3652465 (UMLS CUI [3])
Communicable Diseases Serious CTCAE Grades
Item
active clinically serious infections (> grade 2 ctcae version 3.0)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Organ Allograft
Item
history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Bleeding tendency
Item
patients with evidence or history of bleeding diasthesis
boolean
C1458140 (UMLS CUI [1])
Dialysis
Item
patients undergoing renal dialysis
boolean
C0011946 (UMLS CUI [1])
Therapeutic radiology procedure
Item
radiotherapy during study or within 4 weeks of start of study drug.
boolean
C1522449 (UMLS CUI [1])
Exposure to Investigational New Drugs
Item
prior exposure to the study drug.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Substance Use Disorders Interfere with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Evaluation Research results | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Evaluation Research results
Item
substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0037403 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0038586 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C3840291 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C1261322 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0037403 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])