Excision Curative Liver carcinoma
Item
1. histologically-proven primary hepatocellular carcinoma with curative resection performed in the 4 - 6 weeks prior to randomization.
boolean
C0728940 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
Age
Item
2. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
3. written, signed and dated informed consent to participate in study
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 0 to 1
boolean
C1520224 (UMLS CUI [1])
Child-Pugh Classification
Item
5. child pugh score ≤ 8
boolean
C2347612 (UMLS CUI [1])
Platelet Count measurement
Item
6. platelet count ≥ 80 x 109 cells/liter
boolean
C0032181 (UMLS CUI [1])
Prothrombin time international normalized ratio (PT-INR)
Item
7. pt-inr ≤ 1.3
boolean
C1821762 (UMLS CUI [1])
Activated Partial Thromboplastin Time measurement
Item
8. aptt ≤ upper limit of normal
boolean
C0030605 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Single tumor Diameter | Hepatectomy
Item
1. pathological confirmation of single tumor < 2 cm in diameter which obtained from the most recent hepatectomy.
boolean
C1298180 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0019144 (UMLS CUI [2])
Immune-mediated thrombocytopenia | Abnormal platelets | Hereditary coagulopathy | Blood Coagulation Disorder Acquired | Heparin antibody | Heparin antibody Test Positive
Item
2. history of immune-mediated thrombocytopenia other platelet abnormalities or other hereditary or acquired coagulopathies, or laboratory evidence of anti-heparin antibodies, or any previous history of having tested positive for anti-heparin antibodies.
boolean
C0272286 (UMLS CUI [1])
C0151854 (UMLS CUI [2])
C0679428 (UMLS CUI [3])
C0005779 (UMLS CUI [4,1])
C0439661 (UMLS CUI [4,2])
C0369324 (UMLS CUI [5])
C0369324 (UMLS CUI [6,1])
C0039593 (UMLS CUI [6,2])
C1514241 (UMLS CUI [6,3])
Neoplasm Metastasis | Cancer Other
Item
3. any evidence of tumor metastasis or co-existing malignant disease
boolean
C0027627 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
Recurrent Hepatocellular Carcinoma | Hepatectomy
Item
4. any prior recurrence of hcc or any liver resection prior to the most recent procedure
boolean
C0861876 (UMLS CUI [1])
C0019144 (UMLS CUI [2])
Disease Except Malignant disease | Operative Surgical Procedure | Exception Hepatectomy | Exception Repeat Surgery Complications Hepatectomy | Communicable Disease | Myocardial Infarction | Cerebrovascular accident | Gastrointestinal Hemorrhage | Postoperative Complications Hepatectomy | Postoperative Complications resolved
Item
5. clinically significant non-malignant disease including, but not limited to, surgery within 6 weeks of randomization (apart from liver resection and re-operation for complications of liver resection), active clinically significant infection within 6 weeks prior to randomization, myocardial infarction within 6 months prior to randomization, cerebrovascular event within 12 months prior to randomization or clinically-significant gastrointestinal bleeding within 12 months prior to randomization. subjects who have experienced post-operative complications of liver resection may be enrolled providing that such complications are fully resolved at the time of screening.
boolean
C0012634 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0442867 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019144 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0035110 (UMLS CUI [4,2])
C0009566 (UMLS CUI [4,3])
C0019144 (UMLS CUI [4,4])
C0009450 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0017181 (UMLS CUI [8])
C0032787 (UMLS CUI [9,1])
C0019144 (UMLS CUI [9,2])
C0032787 (UMLS CUI [10,1])
C1514893 (UMLS CUI [10,2])
Communicable Disease Uncontrolled | Communicable Disease Serious
Item
6. subjects with uncontrolled infection or serious infection within the past 4 weeks.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Prior Therapy Liver carcinoma | Chemotherapy | Therapeutic radiology procedure | Molecular Targeted Therapy | Vaccines | Transarterial embolization | Transarterial Chemoembolization | Transplantation of liver | Excision prior to Hepatectomy | Neoadjuvant Therapy | Perioperative Care | Postoperative Care | Embolization of portal vein Preoperative allowed | Transplantation of liver Planned
Item
7. history of prior hcc therapy including chemotherapy, radiotherapy, molecular targeting agents, vaccines, transarterial embolization (tae), transarterial chemoembolization (tace), liver transplantation or surgical resection prior to the most recent hepatectomy, at any time prior to randomization. this includes pre-, peri- and post-operative treatments. pre-operative portal vein embolization is permitted. subjects should not be enrolled if, at the time of randomization, it is planned that they will subsequently undergo liver transplantation regardless of tumor recurrence.
boolean
C1514463 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C2699893 (UMLS CUI [4])
C0042210 (UMLS CUI [5])
C3163695 (UMLS CUI [6])
C3539919 (UMLS CUI [7])
C0023911 (UMLS CUI [8])
C0728940 (UMLS CUI [9,1])
C0332152 (UMLS CUI [9,2])
C0019144 (UMLS CUI [9,3])
C0600558 (UMLS CUI [10])
C0150706 (UMLS CUI [11])
C0032786 (UMLS CUI [12])
C0578122 (UMLS CUI [13,1])
C0445204 (UMLS CUI [13,2])
C0683607 (UMLS CUI [13,3])
C0023911 (UMLS CUI [14,1])
C1301732 (UMLS CUI [14,2])
Aspirin U/day | Vitamin K antagonists | Exception Prophylactic treatment Low dose | heparin | Antiplatelet Agents | abciximab | clopidogrel | Dipyridamole | Ticlopidine | tirofiban
Item
8. concomitant use of aspirin (> 150 mg/day), vitamin k antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomization, or other anti-platelet drugs (e.g. abciximab, clopidogrel, dipyridamole, ticlopidine and tirofiban). low dose aspirin (≤ 150 mg/day) and low-dose prophylactic vitamin k antagonists (e.g. warfarin ≤ 1 mg/day) are permitted as concomitant medications.
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C3653316 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0199176 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C0019134 (UMLS CUI [4])
C0085826 (UMLS CUI [5])
C0288672 (UMLS CUI [6])
C0070166 (UMLS CUI [7])
C0012582 (UMLS CUI [8])
C0040207 (UMLS CUI [9])
C0247025 (UMLS CUI [10])
Allergy to X-ray contrast media | Allergic reaction to iodinated contrast material | Allergic Reaction Non-iodinated X-ray contrast media | Anaphylaxis reaction to contrast material | Pretreatment Steroids Unsuccessful | Pretreatment Histamine Antagonists Unsuccessful | Study Subject Inappropriate CT scanning | Medical contraindication CT scanning | Magnetic metal Implants | Claustrophobia Profound
Item
9. history of allergic, anaphylactic or other significant adverse reaction to radiographic contrast media (iodinated or non-iodinated), which cannot be managed by pre-treatment with agents such as steroids or anti-histamines, and which, in the opinion of the investigator, renders the subject unsuitable for routine ct scanning. subjects who are contra-indicated for ct scanning for other reasons (e.g. ferromagnetic implants, profound claustrophobia), should not be enrolled.
boolean
C0570563 (UMLS CUI [1])
C2215738 (UMLS CUI [2])
C1527304 (UMLS CUI [3,1])
C0361987 (UMLS CUI [3,2])
C2215729 (UMLS CUI [4])
C3539076 (UMLS CUI [5,1])
C0038317 (UMLS CUI [5,2])
C1272705 (UMLS CUI [5,3])
C3539076 (UMLS CUI [6,1])
C0019590 (UMLS CUI [6,2])
C1272705 (UMLS CUI [6,3])
C0681850 (UMLS CUI [7,1])
C1548788 (UMLS CUI [7,2])
C0040405 (UMLS CUI [7,3])
C1301624 (UMLS CUI [8,1])
C0040405 (UMLS CUI [8,2])
C0439876 (UMLS CUI [9,1])
C0021102 (UMLS CUI [9,2])
C0008909 (UMLS CUI [10,1])
C0439808 (UMLS CUI [10,2])
Inflammatory Bowel Disease | Bleeding tendency Abnormal | Bleeding risk Due to Open wound | Bleeding risk Due to Surgery Planned
Item
10. subjects with history of inflammatory bowel disease, any other abnormal bleeding tendency, or subjects at risk of bleeding due to open wounds or planned surgery.
boolean
C0021390 (UMLS CUI [1])
C1458140 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C3251812 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0332798 (UMLS CUI [3,3])
C3251812 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C1301732 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling
Item
11. women who are pregnant or breast-feeding or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Substance Use Disorders Impairing Protocol Compliance
Item
12. active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the subject to comply with the protocol.
boolean
C0038586 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Investigational New Drugs | Antineoplastic Agents
Item
13. subjects who received other investigational or anti-neoplastic medication within the past 4 weeks.
boolean
C0013230 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Therapy, Investigational | Laboratory Procedures | Imaging studies | Scientific investigation
Item
14. current participation in any other clinical study or research project which involves administration of a pharmaceutical product or experimental treatment, or which involves protocol-specified laboratory tests, imaging studies or other investigations.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C1881134 (UMLS CUI [5])
C0683933 (UMLS CUI [6])