Actively Recruiting
Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2024-10-22
12
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 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
- ECOG performance status score of 0 to 1
- Willing to undergo surgery after induction therapy
- No significant contraindications to MEK and BRAF inhibitors
- Adequate major organ function including specified hematological, biochemical, and coagulation parameters
- Women of childbearing age must use effective contraception, have a negative pregnancy test within 7 days before enrollment, and agree to contraception during and for 16 weeks after study treatment
- Male subjects with partners of childbearing age must use effective contraception during and for 16 weeks after study treatment
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Previous treatment with dabrafenib, trametinib, or other BRAF/MEK inhibitors
- Active autoimmune diseases requiring systemic immunosuppression (stable conditions allowed)
- Congenital or acquired immunodeficiency, active hepatitis B or C infection
- Known allergy to study drugs or severe allergic reactions to monoclonal antibodies or targeted therapies
- Recent myocardial infarction, severe or unstable angina, heart failure class II or higher, significant arrhythmias, or symptomatic congestive heart failure within 6 months
- Live vaccination within 4 weeks before first study drug dose (seasonal inactivated vaccines allowed)
- History of allogeneic organ or hematopoietic stem cell transplantation
- Known substance abuse or drug addiction
- Pregnant or breastfeeding women
- Diagnosed with other tumors within 5 years except certain treated and cured cancers or benign tumors
- Other severe physical or mental diseases or lab abnormalities increasing risk or interfering with study, per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here