Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma (NCT06653517) | Clinical Trial Compass
RecruitingPhase 2
Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
China12 participantsStarted 2023-01-01
Plain-language summary
This 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 18-65 years;
✓. Diagnosed with solid/multicystic type ameloblastoma with confirmed BRAF V600E mutation by next-generation sequencing (NGS);
✓. Requires mandibular segmental resection at diagnosis, confirmed by two or more chief physicians;
✓. No distant metastasis or malignancy;
✓. ECOG score 0-1;
✓. Willing to undergo surgery after induction therapy;
✓. No significant contraindications to MEK and BRAF inhibitors;
✓. Major organ function meets the following standards:
Exclusion criteria
✕. Previous use of dabrafenib, trametinib, or other BRAF/MEK inhibitors;
✕. Active autoimmune diseases (stable conditions not requiring systemic immunosuppression allowed);
✕. Congenital or acquired immunodeficiency (e.g., HIV), active hepatitis B (HBV-DNA ≥ 10\^4 copies/ml), or hepatitis C (positive HCV antibody and HCR-RNA above the detection limit);
✕. Known allergy to study drugs or their excipients, or severe allergic reactions to other monoclonal antibodies or targeted drugs;
✕. Myocardial infarction, severe/unstable angina, NYHA class II or higher heart failure, significant arrhythmias, or symptomatic congestive heart failure within 6 months before enrollment;
What they're measuring
1
Proportion of Patients Eligible for Mandibular Continuity-Preserving Surgery
Timeframe: After completion of two 30-day cycles of therapy (approximately 2 months)
2
Proportion of Non-radical Resectable Cases Becoming Resectable
Timeframe: After completion of two 30-day cycles of therapy (approximately 2 months)
Trial details
NCT IDNCT06653517
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
✕. Live vaccination within 4 weeks before the first dose of study drugs (inactivated virus vaccines allowed for seasonal flu, but live attenuated intranasal vaccines not allowed);
✕. History of allogeneic organ or hematopoietic stem cell transplantation;
✕. Known history of substance abuse or drug addiction;