Colorectal Cancer
Conditions
Interventions
Study Group:Metformin 250mg per day combine with FOLFOX + Bevacizumab
Control Group:FOLFOX + Bevacizumab
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient has fully understood the risk of this study and signed the informed consent voluntarily; 2. The colorectal cancer was diagnosed by histology and / or cytology, and the patient has no history of diabetes; 3. The patient was not treated after the diagnosis; 4. 18 years old or older; 5. The score of U.S. Eastern Cooperative Oncology Group performance status (ECOG PS) =2 (0~2); 6. According to the guidelines, the patient's treatment are recommend to use FOLFOX as the first-line chemotherapy or FOLFOX combined with targeted drugs (bevacizumab); 7. There is measurable mass, which meet the requirements of the evaluation criteria for the curative effect of solid tumor (RECIST 1.1); 8. The survival to be expected for more than 12 weeks; 9. Organ functions meet the following criteria: the evaluation of cardiac function: left ventricular ejection fraction is more than 50% (echocardiography); neutrophil: >1.5 * 10^9/l, platelet: >100 * 10^9/l, hemoglobin:> 9g/dl; renal creatinine clearance rate >30ml/min, serum creatinine: <2mg/dl (177umol/l); liver transaminase less than 2.5ULN(less than 5ULN with liver metastasis), alkaline phosphatase (less than 5ULN with liver metastasis, less than 10ULN with bone metastasis ), total bilirubin <1.5ULN; 10. Premenopausal women must for urine or blood tests to rule out pregnancy.
Exclusion criteria
Exclusion criteria: 1. The patient has contraindication to use metformin: (1) moderate (grade 3b) and severe renal failure or renal insufficiency [Cr<45ml /min or eGFR< 45ml / (min 1.73m2)]; (2) diseases that cause tissue hypoxia, especially the deterioration of acute diseases or chronic diseases, such as decompensated heart failure, respiratory failure, recent onset myocardial infarction and shock; (3) severe infection and trauma, large surgical operation, low blood pressure, etc.; (4) those who are known to be allergic to metformin hydrochloride; (5) acute or chronic metabolic acidosis, including or without comatose DKA (DKA needs to be treated with insulin); (6) alcoholics; (7) patients receiving intravascular injection of iodized iodide can temporarily disable this product; (8) the deficiency of vitamin B12 and folic acid was not corrected; 2. Previously used targeted drugs; 3. The patient is in the clinical studies of other drugs such as chemotherapy or targeted drugs; 4. There were second primary malignancies detected in clinical trials, or other malignant tumors in the past 5 years; 5.The patient had ischemic heart disease in the past 1 years (angina or myocardial infarction), or patients with high risk of heart failure, or uncontrolled arrhythmia; 6. Severe active inflammation, including tuberculosis and HIV; 7. Long-term immunization or hormone therapy, with the exception of physiological dose of hormone replacement therapy; 8. Drug or alcohol addiction; 9. Pregnant or lactation; 10. Patients and their spouses refuse to use contraceptives during the study; 11. With other unrelated refractory disease, which affect the survival of patient; 12.Researchers believe that the patient has clinical or laboratory abnormalities or compliance problems which is not suitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, Progression-Free-Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactShan Zeng
Xiangya Hospital, Central South University
Outcome results
None listed