criteria Fulfill
Item
patients will be eligible for enrollment if they fulfill all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Colorectal cancer metastatic
Item
1. metastatic colorectal cancer
boolean
C0948380 (UMLS CUI [1])
Colorectal Carcinoma
Item
2. histologically or cytologically proven colorectal cancer
boolean
C0009402 (UMLS CUI [1])
Survival time Expected
Item
3. expected survival of at least 4 months.
boolean
C2919552 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Pretreatment Quantity
Item
4. not more than 2 different pretreatment regimens
boolean
C3539076 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
5. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
A33 monoclonal antibody
Item
6. within the 2 weeks prior to the first dose of hua33, the following vital laboratory parameters:
boolean
C0392959 (UMLS CUI [1])
Laboratory Results
Item
lab parameter range
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count
Item
neutrophil count > 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 150 x 109/l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin < 2 mg/dl
boolean
C1278039 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance >50 ml/ min
boolean
C0373595 (UMLS CUI [1])
Age
Item
7. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
8. able and willing to give valid written informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Reasons
Item
patients will be excluded from the study for any of the following reasons:
boolean
C2828389 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
CNS metastases | New Lesion X-Ray Computed Tomography | Lesion Enlarged X-Ray Computed Tomography | New Lesion Magnetic Resonance Imaging | Lesion Enlarged Magnetic Resonance Imaging
Item
1. untreated active metastatic disease to the central nervous system defined as new or enlarging lesions on ct or mri.
boolean
C0686377 (UMLS CUI [1])
C2986548 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0442800 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C2986548 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0221198 (UMLS CUI [5,1])
C0442800 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
Operative Surgical Procedures Metastatic malignant neoplasm to brain | Therapeutic radiology procedure Metastatic malignant neoplasm to brain | A33 monoclonal antibody
Item
2. surgery or radiotherapy of brain metastases within 3 months prior to the first dose of hua33.
boolean
C0543467 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C0392959 (UMLS CUI [3])
Neoplasm Metastasis Involvement with Liver
Item
3. metastatic disease involving > 50% of liver volume.
boolean
C0027627 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
Illness Serious | Communicable Diseases Serious Requirement Antibiotics | Blood Coagulation Disorders
Item
4. other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0003232 (UMLS CUI [2,4])
C0005779 (UMLS CUI [3])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Nitrosoureas
Item
5. chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0028210 (UMLS CUI [4])
oxaliplatin
Item
6. previous treatment with oxaliplatin.
boolean
C0069717 (UMLS CUI [1])
A33 monoclonal antibody | A33 monoclonal antibody Fragment
Item
7. previous treatment with hua33 monoclonal antibody or antibody fragment.
boolean
C0392959 (UMLS CUI [1])
C0392959 (UMLS CUI [2,1])
C0332255 (UMLS CUI [2,2])
systemic steroids | Topical corticosteroids | inhaled steroids
Item
8. concomitant treatment with systemic corticosteroids. topical or inhalational corticosteroids are permitted.
boolean
C2825233 (UMLS CUI [1])
C0304604 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
9. known hiv, hepatitis b or c positivity.
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Mental impairment Informed Consent Limited | Mental impairment Protocol Compliance Limited
Item
10. mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
boolean
C1112722 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1112722 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Follow-up Patient Availability Lack
Item
11. lack of availability of the patient for clinical and laboratory follow-up assessment.
boolean
C3274571 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
Study Subject Participation Status | Investigational New Drugs
Item
12. participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
13. pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Refused | Childbearing Potential Contraceptive methods Unable
Item
14. women of childbearing potential: refusal or inability to use effective means of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])