OncoMatch/Clinical Trials/NCT05962502
Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
Is NCT05962502 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cetuximab and irinotecan for metastatic colorectal cancer.
Treatment: Cetuximab and irinotecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Blood-based ctDNA testing shows that both RAS and BRAF genes are wild-type after second-line therapy progression
Required: NRAS wild-type
Blood-based ctDNA testing shows that both RAS and BRAF genes are wild-type after second-line therapy progression
Required: HRAS wild-type
Blood-based ctDNA testing shows that both RAS and BRAF genes are wild-type after second-line therapy progression
Required: BRAF wild-type
Blood-based ctDNA testing shows that both RAS and BRAF genes are wild-type after second-line therapy progression
Excluded: MMR deficient
dMMR/MSI-H mCRC [excluded]
Excluded: MSH2 MSI-H
dMMR/MSI-H mCRC [excluded]
Disease stage
Metastatic disease required
objectively measurable lesions according to RECIST v1.1 criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: fluorouracil compound
previously treated with fluorouracil compounds
Must have received: oxaliplatin
previously treated with oxaliplatin
Must have received: irinotecan
previously treated with irinotecan
Lab requirements
Blood counts
platelets > 90 × 10^9/L; leukocytes > 3 × 10^9/L; neutrophils > 1.5 × 10^9/L; hemoglobin > 8.0g/100ml
Kidney function
Serum creatinine < 1.5 x ULN, or calculated creatinine clearance ≥ 50 ml/min (using the Cockcroft Gault formula)
Liver function
Serum bilirubin ≤ 1.5 x ULN and transaminases ≤ 5 x ULN; Liver function: Child-Push score: Class A
Normal hematologic function (platelets > 90 × 10^9/L; leukocytes > 3 × 10^9/L; neutrophils > 1.5 × 10^9/L; hemoglobin > 8.0g/100ml). Serum bilirubin ≤ 1.5 x ULN and transaminases ≤ 5 x ULN. 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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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