Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
Trial Parameters
Brief Summary
This is a single-arm, open-label, phase II clinical trial. The goal of this study is to evaluate the efficacy and safety of cetuximab plus irinotecan in patients with NeoRAS wild-type primary left-sided mCRC in third-line therapy.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically confirmed colorectal adenocarcinoma. 3. Patients with initial RAS mutant, BRAF wild-type left-sided mCRC. 4. Progression after standard first-line and second-line therapy (previously treated with fluorouracil compounds, oxaliplatin and irinotecan). 5. Tumor progression within 3 months during or after irinotecan-containing regimen. 6. Blood-based ctDNA testing shows that both RAS and BRAF genes are wild-type after second-line therapy progression . 7. There are objectively measurable lesions according to RECIST v1.1 criteria. 8. Normal hematologic function (platelets \> 90 × 109/L; leukocytes \> 3 × 109/L; neutrophils \> 1.5 × 109/L; hemoglobin \> 8.0g/100ml). 9. Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN) and transaminases ≤ 5 x ULN. 10. Normal coagulation function, albumin ≥ 35 g/L. 11. Liver function: Child-Push score: Class A. 12. Serum creatinine \< 1.5 x ULN, or calculated creatinine clearance ≥ 50 ml/min (using t