Liver carcinoma Inappropriate Excision | Liver carcinoma Inappropriate Transplantation of liver | Liver carcinoma Inappropriate Local ablative therapy
Item
1. adults patients with a diagnosis of hcc which is not amenable to surgical resection, liver transplantation or local ablative therapy
boolean
C2239176 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0023911 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0547070 (UMLS CUI [3,3])
Absence Neoplasm Metastasis Extrahepatic
Item
2. without metastasis out of liver
boolean
C0332197 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
Neoplasm Lesion Quantity
Item
3. 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])
Measurable lesion Dimensions Quantity
Item
1. 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])
Absence Operative Surgical Procedures Lesion | Absence Therapeutic radiology procedure Lesion | Absence Radiofrequency ablation Lesion | Absence Percutaneous ethanol injection therapy Lesion | Absence Acetic Acid Injection Lesion | Absence Cryosurgery Lesion
Item
2. the lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
boolean
C0332197 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0850292 (UMLS CUI [3,2])
C0221198 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C1535909 (UMLS CUI [4,2])
C0221198 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0000983 (UMLS CUI [5,2])
C1828121 (UMLS CUI [5,3])
C0221198 (UMLS CUI [5,4])
C0332197 (UMLS CUI [6,1])
C0010408 (UMLS CUI [6,2])
C0221198 (UMLS CUI [6,3])
ECOG performance status
Item
4. ecog performance status (ps) <2
boolean
C1520224 (UMLS CUI [1])
Absence Antiangiogenic therapy Targeted | Metronomic Chemotherapy allowed | Systemic Chemotherapy Discontinued
Item
5. no prior targeted antiangiogenic therapy. metronomic chemotherapies are allowed. at least 4 weeks since prior systemic chemotherapy
boolean
C0332197 (UMLS CUI [1,1])
C2363719 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C1881814 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C1883256 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Child-Pugh Classification
Item
6. child-pugh class a or b
boolean
C4050412 (UMLS CUI [1])
Renal Insufficiency Absent | Creatinine clearance measurement | Dialysis
Item
7. 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])
Comprehension Study Protocol | Informed Consent
Item
8. ability to understand the protocol and to agree to and sign a written informed consent document -
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Hepatitis B Surface Antigens Negative | alpha-Fetoproteins Negative
Item
1. hbsag(-),afp(-).
boolean
C0019168 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0002210 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Prothrombin time increased
Item
2. prothrombin time prolonged more than 4s.
boolean
C0151872 (UMLS CUI [1])
Platelet Count measurement
Item
3. blood platelets count less than 50000/l.
boolean
C0032181 (UMLS CUI [1])
Kidney Failure Requirement Dialysis
Item
4. renal failure requiring dialysis.
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
Hepatic impairment Child-Pugh Classification
Item
5. child-pugh class c hepatic impairment.
boolean
C0948807 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Gastrointestinal Hemorrhage
Item
6. clinically significant gastrointestinal bleeding within 30 days prior to study entry.
boolean
C0017181 (UMLS CUI [1])
Organ Allograft
Item
7. history of organ allograft.
boolean
C0178784 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
Substance Use Disorders Interfere with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Mental condition Interferes with Evaluation Research results | Social Condition Interferes with Evaluation Research results
Item
8. 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 [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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])
C0038586 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C0037403 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
9. 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])
Pregnancy | Breast Feeding
Item
10. pregnant or breast-feeding patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])