NCT05962502 Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
| NCT ID | NCT05962502 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Metastatic Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 54 participants in total. It began in 2023-08-24 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-arm, open-label, phase II clinical trial. The goal of this study is to evaluate the efficacy and safety of cetuximab plus irinotecan in patients with NeoRAS wild-type primary left-sided mCRC in third-line therapy.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically confirmed colorectal adenocarcinoma. 3. Patients with initial RAS mutant, BRAF wild-type left-sided mCRC. 4. Progression after standard first-line and second-line therapy (previously treated with fluorouracil compounds, oxaliplatin and irinotecan). 5. Tumor progression within 3 months during or after irinotecan-containing regimen. 6. Blood-based ctDNA testing shows that both RAS and BRAF genes are wild-type after second-line therapy progression . 7. There are objectively measurable lesions according to RECIST v1.1 criteria. 8. Normal hematologic function (platelets \> 90 × 109/L; leukocytes \> 3 × 109/L; neutrophils \> 1.5 × 109/L; hemoglobin \> 8.0g/100ml). 9. Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN) and transaminases ≤ 5 x ULN. 10. Normal coagulation function, albumin ≥ 35 g/L. 11. Liver function: Child-Push score: Class A. 12. Serum creatinine \< 1.5 x ULN, or calculated creatinine clearance ≥ 50 ml/min (using the Cockcroft Gault formula). 13. ECOG PS score 0-2. 14. Life expectancy \> 3 months. 15. Sign written informed consent. 16. Willing and able to be followed up until death or end of study or study termination. Exclusion Criteria: 1. Primary right-sided mCRC. 2. dMMR/MSI-H mCRC. 3. Patients with initial RAS wild-type or BRAF mutant mCRC. 4. ctDNA testing shows that RAS or BRAF gene is mutant mCRC after second-line therapy. 5. Serious arterial embolism or ascites. 6. Serious bleeding tendency or coagulation disorder. 7. Serious uncontrolled systemic complications such as infection or diabetes. 8. Clinically significant cardiovascular disease such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medical treatment. Unstable angina, congestive heart failure (NYHA class 2-4), cardiac arrhythmia requiring medication. 9. History or physical evidence of central nervous system disease (e.g., primary brain tumor, epilepsy uncontrolled by standard of care, any history of brain metastases or stroke). 10. Other malignancies (except cutaneous basal cell carcinoma and/or cervical carcinoma in situ of the cervix and/or thyroid carcinoma after radical surgery) within the past 5 years. 11. Hypersensitivity to any drug in the study. 12. Pregnant and lactating women. 13. Women of childbearing age (\< 2 years after last menstruation) or men of fertile potential who are not using or refuse to use effective non-hormonal contraception (intrauterine contraceptive ring, barrier contraceptives combined with spermicidal gel, or surgical sterilization). 14. Unable or unwilling to comply with the study protocol. 15. Patients with any other diseases, dysfunction caused by metastatic lesions, or suspected disease found by physical examination, indicating possible contraindications to the use of the investigational drug or putting the patients at high risk of treatment-related complications.
Contact & Investigator
Ruihua Xu, MD, PhD
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT05962502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05962502 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05962502 currently recruiting?
Yes, NCT05962502 is actively recruiting participants. Contact the research team at xurh@sysucc.org.cn for enrollment information.
Where is the NCT05962502 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05962502 clinical trial?
NCT05962502 is sponsored by Sun Yat-sen University. The principal investigator is Ruihua Xu, MD, PhD at Sun Yat-sen University. The trial plans to enroll 54 participants.
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