Informed Consent
Item
1. written inform consent form
boolean
C0021430 (UMLS CUI [1])
Adenocarcinoma of large intestine
Item
2. histologically or cytologically confirmed colorectal adenocarcinoma
boolean
C1319315 (UMLS CUI [1])
Age
Item
3. age≥18 and ≤80 years old
boolean
C0001779 (UMLS CUI [1])
Colorectal Carcinoma Primary | Secondary malignant neoplasm of liver | Lesion of liver Unresectable | Primary Lesion Excision
Item
4. primary colorectal cancer and liver metastases,liver lesions determined to be unresectable by multidisciplinary team (mdt) (primary lesions surgically removed)
boolean
C0009402 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0494165 (UMLS CUI [2])
C0577053 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C1402294 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
Neoplasm Metastasis Simultaneous | Neoplasm Metastasis | Other Coding
Item
5. simultaneity or heterochrony metastases
boolean
C0027627 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Colorectal Carcinoma Lesion Location
Item
6. colorectal cancer lesions from anal edge at least 8 cm
boolean
C0009402 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Chemotherapy Absent | Targeted Therapy Absent
Item
7. within 6 months did not receive any chemotherapy, including targeted therapy
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable lesion Quantity CT scan | Lesion Diameter
Item
8. one or more measurable lesions, conventional computed tomography(ct) scanning measurement diameter at least 20 mm [response evaluation criteria in solid tumors(recist) standard]
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
ECOG performance status
Item
9. eastern collaborative oncology group(ecog) 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
10. expected lifetime at least for 12 weeks
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function Total | Liver function Total | Renal function Total | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Alkaline phosphatase measurement | Creatinine measurement, serum
Item
11. screening within 7 days, the ability of bone marrow, liver and kidney function reserve enough;absolute neutrophil count(anc)≥1.5x109/l; hemoglobin≥9.0g/dl; platelet count≥80 x109/l; total bilirubin(tbil)≤1.5 x upper level of normal range(uln); alanine aminotransferase(alt) and aspartate aminotransferase(ast)≤2.5 x uln(patients with hepatic metastasis≤5x uln); alkaline phosphatase≤4 x uln; serum creatinine≤1.5 x uln;
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0439810 (UMLS CUI [3,2])
C0948762 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
C0494165 (UMLS CUI [10])
C0201850 (UMLS CUI [11])
C0201976 (UMLS CUI [12])
Childbearing Potential Contraceptive methods
Item
12. women of reproductive age should take effective contraceptive measures;
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Cardiac Arrhythmia Requirement Pharmaceutical Preparations | Exception Adrenergic beta-1 Receptor Antagonists | Exception Digoxigenin | Coronary Artery Disease Symptomatic | Myocardial Ischemia | Myocardial Infarction | Congestive heart failure New York Heart Association Classification
Item
1. arrhythmia requiring medication(except β- receptor blocking pharmacon and digoxigenin),symptomatic coronary artery disease and myocardial ischemia [myocardial infarction (≤6months before enrollment)],congestive heart failure [≥new york heart association(nyha)2];
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012264 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0151744 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0018802 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
2. history of hiv infection,chronic hepatitis b or hepatitis c of active phase(high copy virus dna);
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Communicable Disease Serious CTCAE Grades
Item
3. other activated serious infection [>national cancer institute-common toxicity criteria(nci-ctc) 3.0];
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Neoplasm Metastasis Extrahepatic
Item
4. any extrahepatic metastases;
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
Seizures Requirement Pharmaceutical Preparations | Steroids | Antiepileptic Agents
Item
5. seizures requiring medication(such as steroids or antiepileptic therapy);
boolean
C0036572 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
C0003299 (UMLS CUI [3])
Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
6. other malignancies in the past 5 years (except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix);
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Chronic inflammatory bowel disease | Intestinal Obstruction
Item
7. chronic inflammatory bowel disease, intestinal obstruction;
boolean
C1856359 (UMLS CUI [1])
C0021843 (UMLS CUI [2])
Drug abuse Interferes with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Drug abuse Influence Evaluation Research results | Medical condition Influence Evaluation Research results | Mental condition Influence Evaluation Research results | Social Conditions Influence Evaluation Research results
Item
8. drug abuse and medicine, psychology or social conditions may interfere with patients to participate in research or the results of the evaluation have influence;
boolean
C0013146 (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])
C0013146 (UMLS CUI [5,1])
C4054723 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C4054723 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C3840291 (UMLS CUI [7,1])
C4054723 (UMLS CUI [7,2])
C1261322 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0037403 (UMLS CUI [8,1])
C4054723 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs
Item
9. known or suspected allergy to any investigational drug in this study;
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])
Patient's condition unstable | Condition At risk Patient safety | Condition At risk Compliance
Item
10. any unstable condition or is likely to endanger the patient safety and compliance situation;
boolean
C0438114 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Contraceptive methods Absent | Contraceptive methods Refused | Contraceptive methods Except Hormonal Contraception
Item
11. pregnant or lactating women not using or refusing to use effective non hormonal means of contraception;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C1705116 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C2985296 (UMLS CUI [5,3])