Wild-type RAS colorectal cancer
Conditions
Interventions
Cetuximab treatment group:None
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Diagnosed with colorectal cancer (including colon cancer and rectal cancer) through pathological histology or cytology examination; 3. Participants who, based on the researcher's judgment combined with clinical experience, believe that using cetuximab N01 injection will bring clinical benefits; 4. Voluntarily participate in this study, sign the informed consent form, and be willing to undergo regular visits and follow-up; 5. Expected survival period >= 3 months (assessed by the clinical doctor).
Exclusion criteria
Exclusion criteria: 1. Allergic to cetuximab N01 injection or any of its components; 2. Presenting with severe complications (such as uncontrolled heart disease, liver and kidney failure, active infection, etc.); 3. Pregnant or lactating women, and patients of reproductive age who cannot take effective contraceptive measures; 4. Patients with mental disorders, cognitive impairment, and those who cannot cooperate with the visits; 5. Participants currently participating in other clinical trials; 6. Patients judged by the clinical doctor to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution of adverse event types: Statistical analysis of the occurrence frequency and severity of various adverse events (such as skin toxicity, gastrointestinal toxicity, infusion reactions, live;Incidence rates of adverse events (AE) and serious adverse events (SAE);; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Progression-Free Survival (PFS);Clinical Benefit Assessment: Analyze the degree of clinical benefit of cetuximab N01 injection treatment by combining the reduction in tumor markers and changes in EORTC QLQ-C30 scale scores;Overall Survival (OS);Objective Response Rate (ORR);Administration Pattern of Cetuximab N01 Injection: Including dose adjustment rate, delayed administration rate, discontinuation rate, and distribution characteristics of combined treatment regimens; | — |
Countries
China
Contacts
Public ContactPing Sun
Yantai Yuhuangding Hospital
Outcome results
None listed