OncoMatch/Clinical Trials/NCT06603376
Irinotecan Hydrochloride Liposome Injection (Ⅱ) Combined with Fluorouracil, Folinic Acid, Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer
Is NCT06603376 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including FOLFIRI + Vemurafenib + Cetuximab and FOLFIRI ± Bevacizumab for colorectal carcinoma.
Treatment: FOLFIRI + Vemurafenib + Cetuximab · FOLFIRI ± Bevacizumab — Based on the upstream signaling features of BRAFV600E and the bypass feedback mechanisms, considering the pro-apoptotic effects of chemotherapy and the synergistic effects of targeted therapy, previous IMPROVEMENT trial creatively explored a balanced chemotherapy-targeted combination approach (FOLFIRI + Vemurafenib + Cetuximab) in advanced colorectal cancer patients with BRAF V600E mutaiton using a signle-arm study design, demonstrating significant therapeutic efficacy in these patietns . To further validate the effectiveness and safety of this regimen and to solidify its clinical value, it is crucial to conduct a randomized, controlled trial. Investigators plan to use the current standard regimen as a control to compare this strategy (FOLFIRI + Vemurafenib + Cetuximab) on a large cohort of patients with BRAFV600E-mutant advanced colorectal cancer in the first-line setting, focusing on its efficacy and safety.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF v600e
Disease stage
Metastatic disease required
Patients must have at least one measurable lesion according to RECIST 1.1 criteria.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Lab requirements
Blood counts
ANC ≥1,500/mm³; Platelet count ≥75,000/mm³
Kidney function
Creatinine ≤1.5x ULN
Liver function
Total bilirubin ≤1.5x ULN; ALT and AST ≤2.5x ULN (≤5x ULN with liver metastasis)
Cardiac function
No myocardial infarction, severe/unstable angina, congestive heart failure >NYHA Class 2, or uncontrolled arrhythmias within 6 months prior to study
Abnormal laboratory test results: Absolute neutrophil count (ANC) <1,500/mm³; Platelet count <75,000/mm³; Total bilirubin >1.5 times the upper limit of normal (ULN); ALT (alanine aminotransferase) and AST (aspartate aminotransferase) >2.5 times ULN (for patients with liver metastasis >5 times ULN); Creatinine >1.5 times ULN; Patients with the following conditions within 6 months prior to the start of the study treatment: myocardial infarction, severe/unstable angina, congestive heart failure greater than NYHA Class 2, uncontrolled arrhythmias, etc.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06603376 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require BRAF?
Yes, BRAF v600e is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages