A Single-arm, Open-label, Phase II Clinical Study of Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
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.
• Age ≥ 18 years.
• Histologically confirmed colorectal adenocarcinoma.
• Patients with initial RAS mutant, BRAF wild-type left-sided mCRC.
• Progression after standard first-line and second-line therapy (previously treated with fluorouracil compounds, oxaliplatin and irinotecan).
• Tumor progression within 3 months during or after irinotecan-containing regimen.
• Blood-based ctDNA testing shows that both RAS and BRAF genes are wild-type after second-line therapy progression .
• There are objectively measurable lesions according to RECIST v1.1 criteria.
• Normal hematologic function (platelets \> 90 × 109/L; leukocytes \> 3 × 109/L; neutrophils \> 1.5 × 109/L; hemoglobin \> 8.0g/100ml).
• Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN) and transaminases ≤ 5 x ULN.
⁃ Normal coagulation function, albumin ≥ 35 g/L.
⁃ Liver function: Child-Push score: Class A.
⁃ Serum creatinine \< 1.5 x ULN, or calculated creatinine clearance ≥ 50 ml/min (using the Cockcroft Gault formula).
⁃ ECOG PS score 0-2.
⁃ Life expectancy \> 3 months.
⁃ Sign written informed consent.
⁃ Willing and able to be followed up until death or end of study or study termination.