unresectable metastatic colorectal cancer and RAS/BRAF wild-type.
Conditions
Interventions
1 group:Cetuximab Beta:
Dose: 500 mg/m2
Route of Administration: Intravenous infusion
Day of Administration: Day 1
Infusion Duration: The injection should last for more than 2 hours but not exceed 4 h
Sponsors
Tianjin People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participates in this study, has good compliance, is able to cooperate with the trial requirements to complete the observation and follow-up, and has signed the informed consent form. 2. Aged 18 to 75 years (at the time of signing the informed consent form). 3. Histologically confirmed adenocarcinoma of the colon or rectum. 4. First occurrence of metastatic lesions (not amenable to radical resection). 5. Confirmed RAS/BRAF wild-type by genetic testing. 6. ECOG performance status of 0 to 1. 7. Estimated survival of >= 12 weeks. 8. Has recovered from the toxicities related to previous treatments before enrollment in the study. 9. Confirmed by CT or MRI, there is at least one measurable lesion that meets the RECIST 1.1 criteria (outside the field of radiotherapy). 10. Fertile subjects must use appropriate contraception during this study and for 120 days after the end of the study, have a negative serum pregnancy test within 7 days before enrollment in the study, and must be non-lactating subjects.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are not eligible for enrollment in this study: 1. Underwent radiotherapy or surgery within 30 days before the start of treatment (previous diagnostic biopsies are excluded). 2. Organ function levels are as follows: Bone marrow: white blood cells (WBC) 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 times the ULN (for those without liver metastasis) or >5 times the ULN (for those with liver metastasis). Kidney: serum creatinine (Cr) >1.5 times the ULN or creatinine clearance rate = 12 weeks 4. Previously received anti-EGFR monoclonal antibodies, EGFR tyrosine kinase inhibitors, or other EGFR-targeted therapies (such as cetuximab, nimotuzumab, panitumumab, etc.). 5. Known hypersensitivity or allergic reactions to any component of the study treatment. 6. History of organ transplantation, autologous/allogeneic stem cell transplantation. 7. Other concomitant anti-tumor treatments. 8. Symptomatic brain and/or leptomeningeal metastases. 9. History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin. 10. Participated in other anti-tumor drug clinical trials within 30 days before enrollment. 11. Currently receiving chronic systemic immunotherapy or hormone therapy other than physiologic replacement therapy. 12. Any unstable systemic disease: including active infection, uncontrolled hypertension, unstable angina, angina that began within the last 3 months, congestive heart failure (New York Heart Association [NYHA] >= Class II), myocardial infarction within 6 months before enrollment, severe arrhythmias requiring drug therapy, liver, kidney, or metabolic diseases. 13. History of acute or subacute intestinal obstruction, or history of inflammatory bowel disease. 14. Patients with severe bone marrow failure. 15. Any disease, metabolic disorder, or suspicion based on physical examination or laboratory findings that the patient has contraindications to the study drug or is at high risk for treatment complications. 16. Known or self-reported human immunodeficiency virus (HIV) infection. 17. HBV-DNA positive (copy number greater than 10³). 18. Pregnant or breastfeeding. 19. Known or self-reported alcohol or drug addiction in the patient, or the investigator believes there are other adverse health conditions or mental states that may affect protocol compliance and assessm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease progression free survival (PFS); | — |
Countries
China
Contacts
Public ContactHao Yan
Tianjin People's Hospital
Outcome results
None listed