Liver cell carcinoma non-resectable Advanced Locally | Liver cell carcinoma non-resectable metastatic
Item
unresectable locally advanced or metastatic hcc;
boolean
C1112459 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1112459 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Diagnostic criteria Fulfill
Item
histologic confirmation not required if other diagnostic criteria are met;
boolean
C0679228 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Cancer treatment Systemic Absent | Chemoembolization | Radioembolisation | Radiofrequency ablation | Local ablative therapy
Item
no previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in phase ib). previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if >6 weeks of first day of study-defined treatment;
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0796679 (UMLS CUI [2])
C2985560 (UMLS CUI [3])
C0850292 (UMLS CUI [4])
C0547070 (UMLS CUI [5])
ECOG performance status | Status Cirrhotic Child-Pugh Classification | Status Cirrhotic Child-Pugh - Total Score
Item
ecog ps 0 or 1; child-pugh cirrhotic status a or b with a score of 7;
boolean
C1520224 (UMLS CUI [1])
C0449438 (UMLS CUI [2,1])
C0439686 (UMLS CUI [2,2])
C4050412 (UMLS CUI [2,3])
C0449438 (UMLS CUI [3,1])
C0439686 (UMLS CUI [3,2])
C4055253 (UMLS CUI [3,3])
Blood Pressure Well controlled | Blood pressure determination | Antihypertensive Agents | Antihypertensive Agents Absent | Hypertensive crisis Absent | Hypertensive Encephalopathy Absent
Item
blood pressure must be well-controlled (less than or equal to 140/90 mmhg at screening) with or without antihypertensive medication. patients must have no history of hypertensive crisis or hypertensive encephalopathy;
boolean
C0005823 (UMLS CUI [1,1])
C3853142 (UMLS CUI [1,2])
C0005824 (UMLS CUI [2])
C0003364 (UMLS CUI [3])
C0003364 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0020546 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0151620 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
c-Met/VEGFR-2 Kinase Inhibitor E7050 | Antiangiogenic therapy
Item
previously received e7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in phase ib only);
boolean
C2830057 (UMLS CUI [1])
C2363719 (UMLS CUI [2])
Metastatic malignant neoplasm to brain | Exception Therapy Adequate | Exception Stable status Asymptomatic | Exception Steroids Absent
Item
presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Palliative course of radiotherapy
Item
palliative radiotherapy is not permitted throughout the study period;
boolean
C0475092 (UMLS CUI [1])
Hemoptysis
Item
active hemoptysis
boolean
C0019079 (UMLS CUI [1])
Non healing wound Serious | Ulcer | Bone fracture
Item
serious non-healing wound, ulcer, or active bone fracture;
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Major surgery | Incisional biopsy | Traumatic injury | Patient need for Major surgery
Item
major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to commencing study treatment, or anticipation of need for a major surgical procedure during the course of the study;
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C0679637 (UMLS CUI [4,2])
Gastrointestinal Hemorrhage | Hemorrhage Requirement Intervention | Variceal Banding | Transjugular intrahepatic portosystemic shunt procedure | Transarterial embolization | Coagulation therapy Topical
Item
clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg. variceal banding, transjugular intrahepatic portosystemic shunt (tips) procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose.
boolean
C0017181 (UMLS CUI [1])
C0019080 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
C4288030 (UMLS CUI [3])
C0339897 (UMLS CUI [4])
C3163695 (UMLS CUI [5])
C0441509 (UMLS CUI [6,1])
C1522168 (UMLS CUI [6,2])