Colorectal Cancer
Conditions
Interventions
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following entry criteria to be enrolled in the study: 1. Aged 18-70 years, male or female; 2. Patients with colorectal cancer confirmed by histopathology or cytology; 3. At least one measurable lesion (long diameter = 10 mm or short diameter = 15 mm for enlarged lymph nodes on spiral CT scan as required by RECIST v1.1; lesions previously treated with local therapy can be used as target lesions after definite progression according to RECIST v1.1 criteria); 4. good performance status, ECOG score: 0 to 2; 5. Expected survival >=3 months; 6. Histological RAS gene detection KRAS, NRAS is wild type; 7. Major organ function meeting the following requirements: blood routine examination: absolute neutrophil count >= 1.5x10^9/L; platelets >=75x10^9/L; hemoglobin >=90 g/L; biochemical examination: serum albumin >=29 g/L; serum total bilirubin 50 mL/min; Coagulation test: International normalized ratio (INR) <=2.3 or prothrombin time (PT) outside the range of normal controls <=6 seconds; Urine test: urine protein < 2 + or 24-hour (h) urine protein quantification < 1.0 g.
Exclusion criteria
Exclusion criteria: 1. known concurrent primary tumor; 2. Patients who are prepared to undergo or have previously undergone organ or allogeneic bone marrow transplantation; 3. moderate or severe ascites with clinical symptoms requiring therapeutic puncture and drainage (except those with only a small amount of ascites shown by imaging but without clinical symptoms); uncontrolled pleural effusion and pericardial effusion; 4. Thrombotic or embolic events within 6 months before the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.; 5. Have clinical symptoms or diseases of the heart that are not well controlled; 6. have high blood pressure that is not well controlled with antihypertensive medications; have had previous hypertensive crisis or hypertensive encephalopathy; 7. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to the start of study treatment; 8. Serious, unhealed or dehisced wounds and active ulcers or untreated fractures; 9. Major surgical treatment (other than diagnosis) within 4 weeks prior to the start of study treatment or anticipation of the need for major surgical treatment during the study; 10. Current or recent use (within 10 days prior to start of study treatment) of aspirin (> 325 mg/day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol; 11. Have had intestinal obstruction and/or have had clinical signs or symptoms of gastrointestinal obstruction, including incomplete obstruction related to pre-existing conditions or requiring routine parenteral hydration, parenteral nutrition, or tube feeding, within 6 months prior to starting study treatment: Patients may be enrolled in the study if they have been treated with definitive (surgical) therapy to resolve symptoms at the time of initial diagnosis of incomplete obstruction, obstructive syndrome, or symptoms of intestinal obstruction; 13. Previous or current central nervous system metastases; 14. Known history of severe hypersensitivity to study regimen chemotherapy agents such as cetuximab, oxaliplatin, irinotecan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RAS gene phenotype;SEN, SPE, ACC, AUC of ROC; | — |
Secondary
| Measure | Time frame |
|---|---|
| progress-free survival; | — |
Countries
China
Contacts
Public ContactTao Jiang
Fujian Medical University Union Hospital
Outcome results
None listed