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A Single-Arm, Phase II, Multicenter Clinical Study of Neoadjuvant Encorafenib Plus Cetuximab N01 and mFOLFOX6 in Patients With Locally Advanced BRAF V600E-Mutant Colorectal Cancer With or Without Resectable Metastases

Study acronym: NEORAF
StatusRecruiting
PhasePhase 2
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a single-arm, multicenter, phase II clinical trial evaluating the safety and efficacy of neoadjuvant encorafenib plus cetuximab N01 and mFOLFOX6 in patients with locally advanced BRAF V600E-mutated colorectal cancer, with or without resectable metastases. Eligible patients will receive 8 weeks of neoadjuvant treatment with encorafenib, cetuximab N01, and mFOLFOX6, followed by tumor response assessment and radical surgery when appropriate. The primary endpoint is 18-month disease-free survival (DFS). Secondary endpoints include perioperative safety, objective response rate, pathological response rate, 1-year DFS, 3-year DFS, overall safety, and quality of life. This study aims to explore whether incorporating BRAF and EGFR targeted therapy into standard chemotherapy in the neoadjuvant setting can improve tumor control and long-term outcomes in this high-risk molecular subgroup of colorectal cancer.
Trial Details
NCT Number NCT07789210
Lead Sponsor Zhejiang University
Conditions Colorectal Cancer, BRAF V600E Mutation Positive, Encorafenib, Cetuximab N01
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov