NCT06547203 Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 34 participants in total. It began in 2024-07-18 with a primary completion date of 2026-07-30.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Histologically confirmed colorectal adenocarcinoma. * Primary tumor located in the right colon. * Metastatic disease with at least one measurable lesion according to RECIST v1.1 criteria. * Histologically tested as RAS/BRAF V600E wild-type and negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions. * 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. * No prior treatment with anti-EGFR or PD-1 antibodies. * 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. * No ascites, normal coagulation function, albumin ≥35 g/L. * 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). * At least one measurable lesion according to RECIST v1.1 criteria. * ECOG performance status of 0-2. * Expected survival \>3 months. * Signed written informed consent. * Willing and able to undergo follow-up until death or study completion or termination. Exclusion Criteria: * Severe arterial thrombosis or ascites. * Bleeding tendencies or coagulation disorders. * Hypertensive crisis or hypertensive encephalopathy. * Severe uncontrolled systemic complications such as infections or diabetes. * Clinically significant cardiovascular diseases such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medication, unstable angina, congestive heart failure (NYHA grade 2-4), or arrhythmias requiring medication. * History of or physical examination showing central nervous system diseases (e.g., primary brain tumor, uncontrolled epilepsy, any history of brain metastasis or stroke). * Other malignancies within the past 5 years (except for basal cell carcinoma of the skin after curative surgery and/or carcinoma in situ of the cervix). * Use of immunosuppressive drugs within 1 week before treatment, excluding nasal, inhaled, or other topical steroids or physiological doses of systemic steroids (i.e., not exceeding 10 mg/day of prednisone or an equivalent dose of other steroids) or steroids used to prevent contrast agent allergies. * Steroid-dependent interstitial lung disease. * Known active autoimmune disease requiring symptomatic treatment or history of such disease within the past 2 years. Patients with vitiligo, psoriasis, alopecia, or -Graves' disease not requiring systemic treatment within the past 2 years, hypothyroidism requiring only thyroid hormone replacement, and type I diabetes requiring only insulin replacement can be enrolled. * Known history of primary immunodeficiency. * Known active tuberculosis. * Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Receipt of any investigational drug treatment within the last 28 days before the study. * Allergy to any drugs in the study. * Pregnant or breastfeeding women. * Women of childbearing potential (within 2 years of last menstruation) or men capable of fathering a child who are not using or refuse to use effective non-hormonal contraceptive methods (e.g., intrauterine device, barrier method combined with spermicide, or sterilization). * Inability or unwillingness to comply with the study protocol. * Presence of any other disease, functional impairment caused by metastatic lesions, or suspicious conditions found during a physical examination indicating a contraindication to the study drugs or high risk for treatment-related complications.

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