OncoMatch/Clinical Trials/NCT06321081
ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
Is NCT06321081 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies irinotecan, cetuximab, envafolimab for ras mutation.
Treatment: irinotecan, cetuximab, envafolimab — This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF wild-type
Required: KRAS wild-type
Required: NRAS wild-type
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cetuximab-containing or irinotecan-containing front-line therapy (cetuximab, irinotecan) — front-line
Efficacy of any front-line therapies containing cetuximab or irinotecan with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1)
Lab requirements
Blood counts
WBC 2.5 d7 10^9/L with ANC 1.5 d7 10^9/L, lymphocyte count 0.5 d7 10^9/L, platelet count 100 d7 10^9/L, and hemoglobin 9 g/dL (may have been transfused)
Kidney function
estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
Liver function
total bilirubin level 1.5 d7 ULN; AST and ALT 2.5 d7 ULN for all subjects or 5 x ULN (for subjects with documented metastatic disease to the liver)
Adequate hematological function defined by white blood cell (WBC) count 2.5 d7 10^9/L with absolute neutrophil count (ANC) 1.5 d7 10^9/L, lymphocyte count 0.5 d7 10^9/L, platelet count 100 d7 10^9/L, and hemoglobin 9 g/dL (may have been transfused). Adequate hepatic function defined by a total bilirubin level 1.5 d7 the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels 2.5 d7 ULN for all subjects or AST and ALT levels 5 x ULN (for subjects with documented metastatic disease to the liver). Adequate renal function defined by an estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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