Adult | Age | Liver carcinoma Inappropriate Excision | Liver carcinoma Inappropriate Local Ablation Therapy
Item
1. adults patients ( 18-75 years of age) with a diagnosis of hcc which is not amenable to surgical resection or local ablative therapy
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C2239176 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0728940 (UMLS CUI [3,3])
C2239176 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0547070 (UMLS CUI [4,3])
Liver carcinoma | Nodule Size | Nodule Feature Vascular Typical | Alpha one fetoprotein measurement
Item
2. histological confirmed hcc or clinical/laboratory diagnosis of hcc or nodules larger than 2 cm with typical vascular features or afp > 200
boolean
C2239176 (UMLS CUI [1])
C0028259 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0028259 (UMLS CUI [3,1])
C2348519 (UMLS CUI [3,2])
C1801960 (UMLS CUI [3,3])
C3538928 (UMLS CUI [3,4])
C0201539 (UMLS CUI [4])
Measurable Disease Liver
Item
3. patient must have quantifiable disease limited to the liver
boolean
C1513041 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Tumor Lesion Quantity | Criteria Fulfill
Item
4. patients must have at least one tumor lesion that meets both of the following criteria:
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Measurable lesion Dimension Quantity
Item
5. the lesion can be accurately measured in at least one dimension according to recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Operative Surgical Procedures Absent | Therapeutic radiology procedure Absent | Radiofrequency ablation Absent | Percutaneous ethanol injection therapy Absent | Acetic Acid Injection Absent | Cryosurgery Absent
Item
6. the lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
boolean
C0543467 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0850292 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1535909 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0000983 (UMLS CUI [5,1])
C1828121 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0010408 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
ECOG performance status
Item
7. ecog performance status (ps) <2
boolean
C1520224 (UMLS CUI [1])
Antiangiogenic therapy Targeted Absent | Metronomic Chemotherapy | Systemic Chemotherapy | Transarterial Chemoembolization | Interferon
Item
8. no prior targeted antiangiogenic therapy. metronomic chemotherapies are allowed. at least 4 weeks since prior systemic chemotherapy,at least 4 weeks since prior tace, at least 4 weeks since prior interferon.
boolean
C2363719 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1881814 (UMLS CUI [2])
C1883256 (UMLS CUI [3])
C3539919 (UMLS CUI [4])
C3652465 (UMLS CUI [5])
Pregnancy Absent
Item
9. not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Liver Dysfunction Absent | Status Cirrhotic Child-Pugh Classification
Item
10. no significant baseline liver dysfunction. cirrhotic status of child-pugh class a only
boolean
C0086565 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2,1])
C0439686 (UMLS CUI [2,2])
C4050412 (UMLS CUI [2,3])
Renal Insufficiency Absent | Creatinine clearance measurement | Dialysis Absent
Item
11. no significant renal impairment (creatinine clearance < 30 ml/minute) or patients on dialysis
boolean
C1565489 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
C0011946 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Exclusion | Communicable Diseases Requirement Antibiotic therapy
Item
12. no current infections requiring antibiotic therapy
boolean
C0680251 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0338237 (UMLS CUI [2,3])
Anticoagulation Therapy Absent | Blood Coagulation Disorders Absent
Item
13. not on anticoagulation or suffering from a known bleeding disorder
boolean
C0003281 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Coronary Artery Disease Unstable Absent | Recent myocardial infarction Absent
Item
14. no unstable coronary artery disease or recent mi
boolean
C1956346 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1998297 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Malignant Neoplasms Except Liver carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Superficial carcinoma of urinary bladder | Exception Curative treatment Malignant Neoplasms
Item
1. previous or concurrent cancer that is distinct in primary site or histology from hcc except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (ta, tis & t1), and 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])
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])
C1336527 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0006826 (UMLS CUI [5,3])
Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis
Item
2. 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])
Hepatic impairment Child-Pugh Classification
Item
3. child-pugh b & c hepatic impairment
boolean
C0948807 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Heart Disease | Congestive heart failure New York Heart Association Classification | Coronary Artery Disease | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxin | Uncontrolled hypertension | Myocardial Infarction Previous allowed
Item
4. history of cardiac disease: > ny heart association (nyha) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. myocardial infarction more than 6 months prior to study entry is permitted.
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0003195 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0304516 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0012265 (UMLS CUI [6,2])
C1868885 (UMLS CUI [7])
C0027051 (UMLS CUI [8,1])
C0205156 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
Communicable Diseases Serious CTCAE Grades
Item
5. active clinically serious infections (> ctcaev3 grade 2)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
HIV Infection
Item
6. known history of hiv
boolean
C0019693 (UMLS CUI [1])
Central Nervous System Neoplasms | Metastatic malignant neoplasm to brain
Item
7. known central nervous system tumors including metastatic brain disease
boolean
C0085136 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Organ allograft
Item
8. history of organ allograft
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Substance Use Disorders | Mental condition Interferes with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Mental condition Interferes with Evaluation Research results | Social Conditions Interfere with Evaluation Research results
Item
9. substance abuse (current), 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])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C0037403 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
10. known or suspected allergy to the investigational agents or any agent given in association with this trial.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Lacking Able to swallow Oral medication
Item
11. patients unable to swallow oral medications.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Gender Barrier Contraception
Item
12. pregnant or breast-feeding patients. women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0004764 (UMLS CUI [4,2])
Ventricular arrhythmia Requirement Anti-Arrhythmia Agents
Item
13. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
boolean
C0085612 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003195 (UMLS CUI [1,3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Disease Management Optimal
Item
14. uncontrolled hypertension defined as systolic blood pressure > 150 mmhg or diastolic blood pressure > 90 mmhg, despite optimal medical management
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0376636 (UMLS CUI [4,1])
C2698651 (UMLS CUI [4,2])
Thrombosis | Embolism | Cerebrovascular accident | Transient Ischemic Attack
Item
15. thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
boolean
C0040053 (UMLS CUI [1])
C0013922 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Pulmonary hemorrhage CTCAE Grades
Item
16. pulmonary hemorrhage/bleeding event > ctcae grade 2 within 4 weeks of first dose of study drug
boolean
C0151701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hemorrhage CTCAE Grades
Item
17. any other hemorrhage/bleeding event > ctcae grade 3 within 4 weeks of first dose of study drug
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Non-healing wound Serious | Ulcer | Bone fracture
Item
18. serious non-healing wound, ulcer, or bone fracture
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])