OncoMatch/Clinical Trials/NCT06547203
Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study
Is NCT06547203 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cetuximab and Toripalimab for colorectal cancer metastatic.
Treatment: Cetuximab · Toripalimab · Irinotecan — The objective of this clinical trial is to evaluate the efficacy and safety of cetuximab combined with PD-1 inhibitor and irinotecan in negative ultraselection RAS/BRAF wild-type refractory right-sided metastatic colorectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Histologically tested as RAS/BRAF V600E wild-type
Required: NRAS wild-type
Histologically tested as RAS/BRAF V600E wild-type
Required: BRAF V600E wild-type
Histologically tested as RAS/BRAF V600E wild-type
Required: PIK3CA wild-type
negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions
Required: PTEN wild-type
negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions
Required: EGFR extracellular domain wild-type
negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions
Required: HER2 (ERBB2) amplification wild-type
negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions
Required: MET amplification wild-type
negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions
Required: ALK fusion wild-type
negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions
Required: RET fusion wild-type
negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions
Required: NTRK1 fusion wild-type
negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: VEGF inhibitor (bevacizumab)
Patients who have progressed after previous treatments including bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil
Must have received: topoisomerase inhibitor (irinotecan)
Patients who have progressed after previous treatments including bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil, with tumor progression occurring during or within 3 months after irinotecan treatment
Must have received: platinum-based chemotherapy (oxaliplatin)
Patients who have progressed after previous treatments including bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil
Must have received: antimetabolite (5-fluorouracil)
Patients who have progressed after previous treatments including bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil
Cannot have received: EGFR-targeted therapy
No prior treatment with anti-EGFR
Cannot have received: anti-PD-1 therapy
No prior treatment with ... PD-1 antibodies
Lab requirements
Blood counts
platelets >90×10^9/L; white blood cells >3×10^9/L; neutrophils >1.5×10^9/L; albumin ≥35 g/L
Kidney function
Serum creatinine less than ULN, or calculated creatinine clearance >50 ml/min (using the Cockcroft-Gault formula)
Liver function
Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, Liver function classified as Child-Pugh grade A
Normal hematological function (platelets >90×10^9/L; white blood cells >3×10^9/L; neutrophils >1.5×10^9/L). Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN. Liver function classified as Child-Pugh grade A. Serum creatinine less than ULN, or calculated creatinine clearance >50 ml/min (using the Cockcroft-Gault formula). Albumin ≥35 g/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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