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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 (Jun 2026). This Phase 2 trial studies Cetuximab and irinotecan for metastatic colorectal cancer.

Phase 2RecruitingSun Yat-sen UniversityNCT05962502Data as of Jun 2026Location: China

Treatment: Cetuximab and irinotecanThis 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Cetuximab and irinotecan

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

Min 2 prior lines

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.

Frequently asked questions

Is NCT05962502 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received fluorouracil compound and oxaliplatin.

Does this trial require KRAS?

Yes, KRAS wild-type is a required biomarker for enrollment.

Does this trial require NRAS?

Yes, NRAS wild-type is a required biomarker for enrollment.

Does this trial require HRAS?

Yes, HRAS wild-type is a required biomarker for enrollment.

Are patients with MMR alterations eligible?

No. MMR deficient is an exclusion criterion.

Are patients with MSH2 alterations eligible?

No. MSH2 MSI-H is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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