Colorectal Cancer
Conditions
Interventions
Experimental group:Cetuximab-targeted combination with irinotecan chemotherapy, the specific regimen is as follows: Cetuximab (trade name: Erbitux) once every two weeks, 500 mg/m2, d1
Irinotecan 180 mg/m2 ivgtt 90 min d1 q2w
Control group:Regorafenib oral treatment, the specific regimen is as follows: regorafenib 120 mg d1-21 q4w
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following entry criteria to be enrolled in the study: 1. Age 18 to 75 years old, male or female; 2. Adenocarcinoma of the colon or rectum diagnosed histologically; 3. Combined with metastatic lesions (cannot be radical resection); 4. RAS gene wild-type detected by tumor tissue or ctDNA within 1 month before enrollment; 5. Punch biopsy or surgical resection histology specimens available for testing or formally reported prior to enrollment; 6. Confirmed by CT or MRI, at least one measurable lesion (non-radiation therapy field) according to RECIST 1.1 criteria; 7. Body condition score 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. Organ function: bone marrow: white blood cell (WBC) 1.5 times the upper limit of normal reference value; 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 drug treatment, 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 10^3); 15. Pregnancy or lactation; 16. Subjects who are known to have alcohol or drug addiction, or other poor health conditions or mental state that may affect the compliance of the protocol and the assessment of trial indicators in the opinion of the investigator, and are not suitable for participation in the study; 17. Lack or limitation of legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Objective response rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactXiaoyan Lin
Fujian Medical University Union Hospital
Outcome results
None listed