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RECRUITING
NCT06653517
PHASE2

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2023-01-01

Completion Date

2029-12-31

Last Updated

2024-10-22

Healthy Volunteers

No

Interventions

DRUG

Dabrafenib

Dosage: 150 mg orally, twice daily (total daily dose of 300 mg) Administration: Administer at approximately 12 hours apart. Take at the same time each day. If a dose is missed and less than 6 hours remain until the next dose, skip the missed dose. Do not open, crush, or break the capsules. Usage in Combination: When used in combination with trametinib, trametinib should be taken once daily at the same time as either the morning or evening dose of dabrafenib to ensure synchronization of the treatment schedule.

DRUG

Trametinib

Dosage: 2 mg orally, once daily Administration: Administer at least 1 hour before or 2 hours after a meal. Take at the same time each day. If a dose is missed, it should be taken no later than 12 hours before the next scheduled dose; otherwise, skip the missed dose. Usage in Combination: When used in combination with trametinib, trametinib should be taken once daily at the same time as either the morning or evening dose of dabrafenib to ensure synchronization of the treatment schedule.

Locations (1)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China