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Exploratory study: Evaluating the efficacy and safety of continuing cetuximab treatment after first-line treatment progression in RAS/BRAF wild-type metastatic colorectal cancer patients

Exploratory study: Evaluating the efficacy and safety of continuing cetuximab treatment after first-line treatment progression in RAS/BRAF wild-type metastatic colorectal cancer patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103271
Enrollment
Unknown
Registered
2025-05-27
Start date
2024-01-26
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RAS/BRAF wild-type metastatic colorectal cancer

Interventions

Experimental group:Continued treatment with cetuximab in patients with wild-type metastatic colorectal cancer who obtained ETS in first-line cetuximab combined with chemotherapy and retested as RAS/BR

Sponsors

Tianjin People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed malignant tumor of colon cancer; 2. Baseline clinical stage of T3-4 and/or N M1; 3. Age 18-70 years old, gender is not limited; 4. Karnofsky Strength Status Score>=70; 5. Patients with RAS/BRAF wild-type confirmed by molecular testing; 6. Initial uncut metastatic colorectal cancer that has received standard chemotherapy plus cetuximab in the first line of treatment; 7. Able to comply with the protocol for the duration of the study; 8. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Those with a history of other malignant diseases in the last 5 years, except for cured skin cancer and carcinoma in situ of the cervix; 3. Those with a history of uncontrolled epilepsy, central nervous system disease, or mental disorder, whose clinical severity may preclude the signing of the informed consent form or affect the patient's compliance with oral medication as judged by the investigator; 4. Clinically serious (i.e., active) cardiac disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) Class II or greater congestive heart failure or severe cardiac arrhythmia requiring pharmacological intervention (see Appendix 12), or history of myocardial infarction within the last 12 months; 5. Patients with autoimmune diseases; 6. Severe uncontrolled recurrent infection, or other serious uncontrolled concomitant diseases; 7. The subject's baseline blood routine and biochemical indexes did not meet the following criteria: hemoglobin>=90g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; platelets>=100×10^9/L; ALT, AST=30 g/L; 8. Those who are allergic to any of the study ingredients.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Objective response rate;

Secondary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactHao Yan

Tianjin People's Hospital

sarahhao99@sina.cn+86 132 0760 3727

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026