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Recruiting Phase 2

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

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About this study

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.

Condition
Colorectal Cancer Metastatic
Tested
Cetuximab, Toripalimab, Irinotecan
Sponsor
Sun Yat-sen University

Who can join

Age
18 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 19

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Study condition: Colorectal Cancer Metastatic
  • 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 20

  • 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.

Where

1 site, 1 recruiting

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.