Colorectal Cancer
Conditions
Interventions
Experimental group:cetuximab 500 mg/m2 d1, combined with irinotecan 180 mg/m2 d1, intravenous drip 90 min d1, every 2 weeks as a cycle, record the disease control. In the maintenance phase1 group, if
Control group:Nil
Sponsors
Medical Oncology Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 71 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Histologically confirmed adenocarcinoma colon or rectum cancer; 3. Combined with metastatic lesions (can not be radical resection); 4. RAS and BRAF wild type; 5. Biopsy or surgical resection histological specimens that can be provided for testing or have been formally reported before enrollment; 6. CT or MRI confirmed that there is at least one measurable lesion (non-radiation therapy field) in accordance with RECIST version 1.1; 7. ECOG 0 ~ 2; 8. Expected survival time is more than 3 months, and the place of residence is convenient for follow-up; 9. Subjects with reproductive potential must receive effective medical contraception (no matter male or female subjects, until 90 days after the last study drug administration); 10. Recovered from toxicities associated with previous treatment before study entry; 11. Voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1. The following conditions occur at the organ function level: Bone marrow: white blood cell (WBC) 1.5 times the upper limit of normal reference value ALT; ALT and AST > 2.5 times the upper limit of normal reference value (without liver metastasis) or > 5 times the upper limit of normal reference value (liver metastasis); kidney: serum creatinine (Cr) > 1.5 times the upper limit of normal or creatinine clearance =II), myocardial infarction within 6 months before enrollment, severe arrhythmia requiring medication, liver, kidney or metabolic disease; 10. Acute or subacute intestinal obstruction, or history of inflammatory bowel disease; 11. subjects with severe bone marrow failure; 12. Any disease, metabolic disorders, or physical examination or laboratory suspicion of patients with contraindications to the study drug or high risk factors for treatment complications; 13. Known or self-reported human immunodeficiency virus (HIV) infection; 14. HBV-DNA positive (copy number greater than 103); 15. Pregnancy or lactation; 16. Subjects who are known to have alcohol or drug addiction, or other adverse health conditions or mental states that may affect the compliance of the protocol and the assessment in the opinion of the investigator are not suitable for participation in the study; 17. Lack or limitation of legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;DCR;ORR;QoL;Safety; | — |
Countries
China
Contacts
Public ContactXiaoyan Lin
Fujian Medical University Union Hospital
Outcome results
None listed