Colorectal Cancer
Conditions
Interventions
A group:Before using cetuximab
B group:After progression of disease:no
Sponsors
Department of Gastroenterology, First Affiliated Hospital of Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The subject will be included,who must meet all the following criteria: 1. Signed written informed consent; 2. Aged: 18 to 80 years; 3. The subject with fertility must use the effective contraceptive measures; 4. Confirmed advanced colorectal cancer histopathologically, either cannot be radically resected or relapse after surgical resection; 5. KRAS wild-type status; 6. Confirmed the presence of at least one measurable lesion in line with RECIST criteria (non-radiotherapy field) by CT or MRI; 7. A life expectancy>12 weeks; 8. KPS score >=60; 9. White blood cell count>=3*10^9/L and neutrophil count>=1.5*10^9/L, platelet count>=100*10^9/L, hemoglobin>=100g/L; 10. Total bilirubin <=1.5 times the upper limit of normal reference value; 11. AST and ALT <=2.5 times the upper limit of normal reference value, AST and ALT for the presence of liver metastases <=5 times the upper limit of normal reference value; 12. Serum creatinine <=1.5 times the upper limit of normal reference value; 13. Recover from the previous treatment-related toxicity before included.
Exclusion criteria
Exclusion criteria: Either of the following which is not one of exclusion criteria will not be enrolled: 1. An organ transplantation or autologous/allogeneic stem cell transplant history; 2. Renal replacement therapy; 3. Other malignancies except CRC in the past five years; 4. Severe cardiovascular diseases such as heart failure (NYHA III-IV grade), uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, myocardial infarction in the past five years and left ventricular ejection fraction lower than the normal range indicated by Doppler ultrasound echocardiography; 5. Acute or sub-acute intestinal obstruction, or a history of inflammatory bowel disease; 6. Severe active infection; 7. HIV infection or chronic hepatitis B or C; 8. Peripheral neuropathy>1 grade; 9. Uncontrolled diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, liver failure; 10. Hypersensitivity or allergic reaction to any ingredients known in study treatment; 11. Pregnancy or breast-feeding; 12. Some medical or psychiatric disorders making subjects unable to complete the study or sign the informed consent; 13. Other serious diseases that researchers believe the subject can not be enrolled; 14. Coagulopathy; 15. Contraindications in colonoscopy or liver biopsy puncture; 16. Contraindications in CT or MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KRAS gene sequence;NRAS gene sequence;BRAF gene sequence;PIK3CA gene sequence;EGFR gene sequence;EGFR gene copy numbers;EGFR expression;Her2 expression;c-Met expression;PTEN expression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactWang Xin
Outcome results
None listed