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OncoMatch/Clinical Trials/NCT06653517

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

Is NCT06653517 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dabrafenib and Trametinib for ameloblastoma.

Phase 2RecruitingShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityNCT06653517Data as of May 2026

Treatment: Dabrafenib · TrametinibThis study aims to evaluate the tumor shrinkage effect of preoperative targeted induction therapy with dabrafenib and trametinib in patients with conventional ameloblastoma harboring the BRAF V600E mutation. The study will assess the proportion of cases where mandibular continuity cannot be preserved that can be converted to cases where mandibular continuity is preserved, as well as the proportion of cases where complete resection is initially not feasible that become resectable.

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Extracted eligibility criteria

Biomarker criteria

Required: BRAF v600e

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: BRAF inhibitor (dabrafenib)

Previous use of dabrafenib

Cannot have received: MEK inhibitor (trametinib)

Previous use of trametinib

Cannot have received: BRAF inhibitor

Previous use of other BRAF inhibitors

Cannot have received: MEK inhibitor

Previous use of other MEK inhibitors

Lab requirements

Blood counts

wbc ≥ 4.0×10^9/l, anc ≥ 1.5×10^9/l, plt ≥ 100×10^9/l, hb ≥ 90g/l (no transfusion or blood products, no use of g-csf or other hematopoietic stimulants within 14 days)

Kidney function

bun/cre ≤ 1.5×uln or creatinine clearance rate ≥ 60 ml/min

Liver function

tbil ≤ 1.5×uln, alt/ast ≤ 2.5×uln

Cardiac function

no myocardial infarction, severe/unstable angina, nyha class ii or higher heart failure, significant arrhythmias, or symptomatic congestive heart failure within 6 months before enrollment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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