Colorectal cancer
Conditions
Interventions
Experimental groupA:mCapOX+ Cetuximab
Experimental groupB:mFOLFOX6+ Cetuximab
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent and can understand and comply with the requirements of the study; 2. Men and women >= 18 years of age; 3. Patients with histologically or cytologically confirmed metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes; 4. Presence of at least one evaluable lesion, as defined in RECIST Version 1.1; 5. With an Eastern Cooperative Oncology Group (ECOG) performance status of = 1.5 x 10^9/L; (2)Platelets >= 75 x 10^9/L; (3)Hemoglobin >= 8 g/dL; (4)Total bilirubin 50 mL/min or serum creatinine <= 1.5 x UNL.
Exclusion criteria
Exclusion criteria: 1. Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded; 2. Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry; 3. Hypersensitivity to any therapeutic agent; 4. Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study; 5. Patients who have failed one or more palliative chemotherapy regimens; 6. Patients with uncontrolled hepatitis B virus ; 7. Peripheral neuropathy >= CTC grade 2; 8. Neurological or psychiatric disorders affecting cognitive performance; 9. Patients with central nervous system metastasis could not be controlled with radiotherapy; 10. Previous enteritis, chronic diarrhea, or recurrent bowel obstruction; uncontrolled bleeding from internal medicine; bowel perforation; 11. Uncontrolled concomitant diseases within 6 months before the study, including unstable angina, acute myocardial infarction, cerebrovascular accident, etc.; 12. Pregnant or lactating patients, or those of childbearing potential who do not take adequate contraceptive measures; 13. History of other malignancies, but no disease-free survival longer than 5 years; 14. Patients concurrently receiving other anti-tumor treatment or participating in other interventional clinical trials; 15. Patients who are unable to comply with this study for psychological, family or social reasons; 16. Patients with other serious diseases that the investigator considers not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Adverse event rate; | — |
Countries
China
Contacts
Public ContactQiu Meng
West China Hospital of Sichuan University
Outcome results
None listed