Combining cetuximab and irinotecan for treating advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of cetuximab combined with irinotecan in patients with NeoRAS wild-type metastatic colorectal cancer who have already undergone standard first and second-line therapies. It is a single-arm, open-label phase II trial aimed at patients who have shown progression after previous treatments. The study seeks to determine if this combination can improve outcomes for patients who have limited options left in their treatment journey.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer center of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Ruihua Xu, MD, PhD — Sun Yat-sen University
• Study coordinator: Ruihua Xu, MD, PhD
• Email: xurh@sysucc.org.cn
• Phone: +86 13922206676

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Second-line combination treatment for MSS metastatic colorectal cancer

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• Combination treatment for advanced colorectal cancer

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• Combination treatment for advanced colorectal cancer with specific mutations

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• Combining ulixertinib with cetuximab and encorafenib for advanced colorectal cancer

  This study is testing a new combination of three drugs to see if they can safely help people with advanced colorectal cancer who haven't responded to other treatments.

  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT05985954

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.