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 (Jun 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
Treatments studied
Targeted therapy
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.
Frequently asked questions
Is NCT06321081 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received cetuximab-containing or irinotecan-containing front-line therapy.
Does this trial require BRAF?
Yes, BRAF wild-type is a required biomarker for enrollment.
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.
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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