left colorectal cancer
Conditions
Interventions
experimental group:Cetuximab combined with capecitabine
control group:capecitabine alone
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years old; 2. ECOG score of physical condition 0-2; 3. Advanced metastatic left colorectal adenocarcinoma confirmed by histology or cytology. There were measurable lesions that met the requirements of RECIST 1.1. 4. K-ras or N-ras genes were wild type; 5. Patients with advanced left-sided colorectal cancer who received disease control (CR, PR or SD) were treated with cetuximab plus FOLFIRI/mFOLFOX6 regimen for 4-6 cycles (8-12 weeks). The first-line chemotherapy lasted at least 4 weeks from the previous radiotherapy, and the assessable lesions were not in the radiation field. The first-line users of mFOLFOX6 regimen should be at least one year away from the end of adjuvant chemotherapy with oxaliplatin.6. Appropriate hematological parameters and liver and kidney functions: absolute number of neutrophils (> 1.5 *10^9/L); platelet count (> 100 *10^9/L); hemoglobin (> 90 g/L); total serum bilirubin ( 50 mL/min); 7. Cardiac function evaluation: left ventricular ejection fraction (> 50%) (echocardiography); 8. Projected survival (> 12 weeks); 9. Patients before admission have fully understood the study and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Surgically resectable CRC patients with RO; 2. Anaphylaxis to cetuximab or capecitabine; 3. Patients receiving adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before admission; 4. Patients undergoing surgery or radiotherapy 4 weeks before admission; 5. Previous use of monoclonal antibodies, inhibition of EGFR signal transduction or EGFR targeted therapy; 6. Those who had received one or more palliative chemotherapy regimens failed; 7. Peripheral neuropathy (> CTC 2); 8. Neurological or psychiatric disorders affecting cognitive ability; 9. Central nervous system metastasis patients; 10. Intestinal obstruction with previous enteritis, chronic diarrhea or recurrent attacks; 11. Uncontrolled concomitant diseases including unstable angina pectoris, acute myocardial infarction, cerebrovascular accident, etc. in the first six months of the study; 12. pregnant or breast-feeding patients, or those with fertility without adequate contraceptive measures; 13. History of other malignant tumors, but no disease survived for more than five years; 14. Simultaneous complications; Other anti-cancer therapies or patients participating in other interventional clinical trials; 15. Severe active inflammation, including tuberculosis and HIV; 16. Long-term immunization or hormone therapy, excluding hormone replacement therapy at physiological doses; 17. drug or alcohol addiction; 18. pregnancy or lactation; 19. Premenopausal women must undergo urine or blood tests to exclude pregnancy; 20. Patients unable to comply with this study due to psychological, family or social reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintaining progression-free survival of treatment;RAS gene status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response;Overall Survival;duration of disease control;Safety;Quality of life of patients; | — |
Countries
China
Contacts
Public ContactHan Yunwei
Affiliated Hospital of Southwest Medical University
Outcome results
None listed