OncoMatch/Clinical Trials/NCT05959356
Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer
Is NCT05959356 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cetuximab + Envafolimab + mFOLFOXIRI and Cetuximab + mFOLFOX6 for metastatic colorectal cancer.
Treatment: Cetuximab + Envafolimab + mFOLFOXIRI · Cetuximab + mFOLFOX6 — The primary aim of phase II CEIL study is to evaluate the efficacy of cetuximab and envafolimab plus mFOLFOXIRI versus cetuximab plus mFOLFOX6 as first line treatment of patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side metastatic colorectal cancer(mCRC), in terms of Progression-free Survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
RAS and BRAF wild-type
Required: NRAS wild-type
RAS and BRAF wild-type
Required: BRAF wild-type
RAS and BRAF wild-type
Required: MMR microsatellite stable
MSS metastatic colorectal adenocarcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: adjuvant/neoadjuvant therapy is considered first-line if recurrence/metastasis occurs during or within 6 months after therapy
The patient has not previously received any systemic treatment specifically targeting advanced or metastatic colorectal cancer, including chemotherapy
Cannot have received: monoclonal antibody targeting EGFR (cetuximab, panitumumab)
monoclonal antibodies such as cetuximab or panitumumab targeting the epidermal growth factor receptor (EGFR)
Cannot have received: monoclonal antibody targeting VEGF (bevacizumab)
bevacizumab targeting the vascular endothelial growth factor (VEGF)
Cannot have received: immune checkpoint inhibitor
immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 antibodies, and anti-CTLA-4 antibodies
Lab requirements
Blood counts
Hemoglobin ≥ 90g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 75 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5 × UNL
Liver function
Serum total bilirubin ≤ 1.5 × upper limit of normal (UNL); AST or ALT ≤ 2.5 × UNL; if there are liver metastases, AST or ALT ≤ 5 × UNL
Hemoglobin ≥ 90g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 75 × 10^9/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (UNL); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × UNL; if there are liver metastases, AST or ALT ≤ 5 × UNL; Serum creatinine ≤ 1.5 × UNL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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