Cetuximab (Erbitux, C225): cetuximab 500 mg/m² repeated every two weeks.
trifluridine/tipiracil: Trifluridine/tipiracil 35 mg/m² (orally for 5 days, followed by 9 days off)
Bevacizumab ( Avastin): bevacizumab 5 mg/kg
Study summary
The objective of this randomized controlled clinical trial is to evaluate the efficacy of ctDNA-guided rechallenge with cetuximab plus trifluridine/tipiracil compared with bevacizumab plus trifluridine/tipiracil in patients with treatment-refractory, RAS/BRAF wild-type metastatic colorectal cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Histologically confirmed colorectal adenocarcinoma
* Initial RAS/BRAF wild-type status
* Received first-line treatment with FOLFOX, FOLFIRI, or FOLFOXIRI combined with cetuximab, with documented clinical benefit (CR/PR/SD) and progression-free survival (PFS) ≥ 6 months
* Disease progression occurred during or within 3 months after cetuximab-based first-line therapy
* Experienced further tumor progression after receiving second-line or subsequent treatments
* At least 4 months have elapsed since the last administration of cetuximab
* At least one measurable lesion according to RECIST v1.1
* RAS/BRAF wild-type status confirmed by blood-based ctDNA testing
* Normal hematologic function (platelets \> 90 × 10⁹/L; white blood cells \> 3 × 10⁹/L; neutrophils \> 1.5 × 10⁹/L; hemoglobin \> 10.0 g/100 ml)
* Serum bilirubin ≤ 1.5 × upper limit of normal (ULN), transaminases ≤ 5 × ULN
* No ascites, normal coagulation function, serum albumin ≥ 35 g/L
* Child-Pugh class A liver function
* Serum creatinine below ULN or calculated creatinine clearance \> 50 ml/min (using the Cockcroft-Gault formula)
* ECOG performance status of 0-1
* Expected survival \> 3 months
* Signed written informed consent
* Willing and able to undergo follow-up until death, study completion, or study termination
Exclusion Criteria:
* Presence of RAS or BRAF gene mutations
* Severe arterial embolism or ascites
* Bleeding tendency or coagulation disorders
* Hypertensive crisis or hypertensive encephalopathy
* Severe and uncontrolled systemic complications such as infections or diabetes
* Clinically significant cardiovascular diseases, including cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medical therapy, unstable angina, congestive heart failure (NYHA class II-IV), or arrhythmias requiring medical treatment History of or physical examination indicating central nervous system diseases (e.g., primary brain tumor, epilepsy not controlled with standard therapy, any brain metastases, or history of stroke)
* History of other malignancies within the past 5 years (excluding adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and/or thyroid cancer)
* Known allergy to any of the study drugs
* Pregnant or breastfeeding women
* Women of childbearing potential (within 2 years of last menstruation) or men with reproductive potential who are not using or refuse to use effective non-hormonal contraception (e.g., intrauterine device, barrier method with spermicidal gel, or sterilization)
* Inability or unwillingness to comply with the study protocol
* Any other disease, functional impairment caused by metastatic lesions, or suspicious findings on physical examination that may indicate contraindications to study treatment or place the patient at high risk of treatment-related complications
Primary outcome measure(s)
Objective Response Rate — Assessed after every 4 cycles (each cycle is 14 days) from treatment initiation until radiographic disease progression, treatment discontinuation, or completion of the 5-year follow-up, whichever occurs first The percentage of patients in a study group who have a partial or complete response to treatment according to RECIST v1.1 criteria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.