Actively Recruiting
Neoadjuvant BRAFV600E-Targeted Therapy for Conventional Ameloblastoma of the Jaw: A Single-Arm Clinical Study
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2024-10-22
12
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosed with solid or multicystic ameloblastoma with confirmed BRAF V600E mutation by next-generation sequencing
- Requires mandibular segmental resection at diagnosis confirmed by two or more chief physicians
- No distant metastasis or malignancy
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Willing to undergo surgery after induction therapy
- No significant contraindications to MEK and BRAF inhibitors
- Adequate major organ function based on blood counts, liver and kidney tests, and coagulation parameters
- Women of childbearing age must use effective contraception and have a negative pregnancy test before enrollment; male participants with partners of childbearing age must also use effective contraception during the study and for 16 weeks after last dose
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Previous use of dabrafenib, trametinib, or other BRAF/MEK inhibitors
- Active autoimmune diseases requiring systemic immunosuppression
- Congenital or acquired immunodeficiency, active hepatitis B or C infection
- Known allergy to study drugs or similar medications
- Recent serious heart conditions such as myocardial infarction or heart failure within 6 months
- Live vaccination within 4 weeks before first dose of study drugs
- History of organ or stem cell transplantation
- Known substance abuse or drug addiction
- Pregnant or breastfeeding women
- Diagnosis of other tumors within 5 years except certain locally treated cancers
- Other severe physical or mental conditions or lab abnormalities increasing risk or interfering with study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 30-day cycles until disease progression, intolerable toxicity, or surgery
Participants take dabrafenib twice daily and trametinib once daily in 30-day cycles. Treatment continues until disease progression, intolerable toxicity, or criteria for surgery are met. Follow-up evaluations are conducted after each of the first two cycles and then every two cycles to assess drug safety and tumor response.
Follow-up visits after each of the first two cycles, then every two cycles thereafter
Duration - Varies depending on surgical scheduling
Participants who meet criteria for mandibular preservation surgery after treatment discontinue medication and undergo planned surgery as confirmed by at least two chief physicians.
1 to 2 visits depending on surgical planning
Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
Z
ZHAO Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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