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OncoMatch/Clinical Trials/NCT06547203

Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study

Is NCT06547203 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Cetuximab and Toripalimab for colorectal cancer metastatic.

Phase 2RecruitingSun Yat-sen UniversityNCT06547203Data as of Jun 2026Location: China

Treatment: Cetuximab · Toripalimab · IrinotecanThe 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Toripalimab

Targeted therapy

Cetuximab

Chemotherapy

Irinotecan

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)

Demographics

Ages ≤ 80

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.

Frequently asked questions

Is NCT06547203 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior EGFR-targeted therapy, anti-PD-1 therapy disqualifies patients from 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.

Does this trial require BRAF?

Yes, BRAF V600E wild-type is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 80 years or younger.

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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