Actively Recruiting
ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC
Led by Sun Yat-sen University · Updated on 2025-06-24
64
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal adenocarcinoma
- Initial RAS/BRAF wild-type status
- Received first-line treatment with FOLFOX, FOLFIRI, or FOLFOXIRI plus cetuximab with clinical benefit and progression-free survival of at least 6 months
- Disease progressed during or within 3 months after first-line cetuximab-based therapy
- Further tumor progression after second-line or later treatments
- At least 4 months since last cetuximab dose
- At least one measurable lesion per RECIST v1.1
- RAS/BRAF wild-type status confirmed by blood-based ctDNA test
- Normal blood counts: platelets > 90 x 10^9/L; white cells > 3 x 10^9/L; neutrophils > 1.5 x 10^9/L; hemoglobin > 10.0 g/100 ml
- Serum bilirubin ≤ 1.5 times upper normal limit; transaminases ≤ 5 times upper normal limit
- No ascites; normal coagulation; serum albumin ≥ 35 g/L
- Child-Pugh class A liver function
- Serum creatinine below upper normal limit or creatinine clearance > 50 ml/min
- ECOG performance status 0-1
- Expected survival longer than 3 months
- Signed informed consent
- Willing and able to complete follow-up until death, study end, or termination
You will not qualify if you...
- Presence of RAS or BRAF gene mutations
- Severe arterial embolism or ascites
- Bleeding tendency or coagulation disorders
- Hypertensive crisis or hypertensive encephalopathy
- Severe uncontrolled infections or diabetes
- Significant cardiovascular diseases within 6 months prior including stroke, heart attack, unstable angina, congestive heart failure NYHA II-IV, or arrhythmias needing treatment
- Central nervous system diseases including brain tumors, uncontrolled epilepsy, brain metastases, or stroke history
- Other cancers within past 5 years except treated basal cell skin cancer, cervical carcinoma in situ, or thyroid cancer
- Known allergy to study drugs
- Pregnant or breastfeeding
- Women of childbearing potential or men with reproductive potential not using effective non-hormonal contraception
- Unwilling or unable to follow study protocol
- Any disease or condition increasing risk of treatment complications or contraindicating study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
D
Deshen Wang, PhD
CONTACT
R
Ruihua Xu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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