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 (May 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
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)
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.
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