Neoadjuvant BRAFV600E-Targeted Therapy for Conventional Ameloblastoma of the Jaw A Single-Arm Clinical Study

What this Trial Is About

Researchers are evaluating the effect of preoperative targeted therapy using dabrafenib and trametinib in patients with conventional ameloblastoma of the jaw who have the BRAF V600E mutation. The main goal is to see if this treatment can shrink tumors enough to allow for mandibular preservation surgery instead of segmental resection and to determine if cases initially not suitable for complete removal become operable. This is a Phase 2 single-arm clinical study focused on improving surgical outcomes for this condition. Participants receive dabrafenib 150 mg twice daily and trametinib 2 mg once daily, taken orally with specific timing instructions related to meals and dose intervals. Treatment is given in 30-day cycles, with evaluations after the first two cycles to monitor tumor shrinkage, drug safety, and side effects. If toxicity is intolerable or the tumor progresses, participants may switch to traditional surgery. Follow-up continues every two cycles until surgery is feasible or tumor shrinkage plateaus. During the study, participants undergo consultations, physical exams, imaging studies, and laboratory tests to assess safety and treatment response. Researchers measure the proportion of patients able to have mandibular preservation surgery and those whose tumors become resectable after therapy. Secondary outcomes include radiological and pathological responses, local recurrence-free survival over three months, and monitoring adverse effects for up to 12 months. The total study duration and safety monitoring extend through these periods to ensure comprehensive evaluation.

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma