| Eligibility |
Inclusion Criteria:
- Histology confirmed ameloblastoma.
- The patient was tested positive for BRAF V600E mutation.
- Eligible patients must have evaluable lesions within the jaw that meet RECIST
criteria.
- Be 18 years or older.
- Laboratory test results:
ANC > 1.5 x 109/L. PLT > 99 x 109/L. Hemoglobin >8 g/dL. Tbili < 1.6 × ULN. AST, ALT and
alkaline phosphate < 2.6 times the upper limit of normal (ULN) . Serum creatinine =1.5
mg/dL, or serum creatinine >1.5 mg/dL, creatinine clearance must be =50ml/min.
PR / INR, PTT = 1.3 × ULN, patients receiving anticoagulation therapy can participate in
the trial if their INR is within the therapeutic range before randomization.
- Patients of childbearing potential must agree to use effective contraception for at
least 6 months after treatment with dabrafenib.
- Be able to swallow and retain oral medications and must not have any clinically
significant gastrointestinal abnormalities that may alter absorption, such as
malabsorption syndrome or major resection of the stomach or intestines.
- The left ventricular ejection fraction is equal to or greater than normal within 1
month of enrollment.
- Voluntarily sign the informed consent form and cooperate with the treatment.
Exclusion Criteria:
- Those who have used BRAF inhibitor treatment in the past.
- Patients with invasive malignant tumors other than ameloblastoma within 3 years,
excluding cancers with high cure rates, such as early cutaneous squamous cell
carcinoma (T1 N0), cervical cancer, early prostate cancer, thyroid cancer, breast
cancer Cancer and malignant tumors with confirmed activating RAS mutations at any
time.
- Those who have had retinal vein occlusion in the past or currently.
- Those with a history of interstitial lung disease or lung inflammation.
- Those suffering from uncontrolled hypertension (systolic blood pressure > 140 mm Hg,
diastolic blood pressure > 90 mm Hg, which cannot be controlled by antihypertensive
treatment), heart failure or other serious medical diseases.
- Patients with previous allergic reactions caused by compounds with similar chemical or
biological components to dabrafenib or trametinib.
- Concomitantly taking strong CYP3A4 or CYP2C8 inhibitors (such as ketoconazole,
nefazodone, clarithromycin, gemfibrozil) or strong inducers (such as rifampicin,
phenytoin, carbamazepine, phenobarbide) appropriate).
- Those who take proton pump inhibitors, H2 receptor antagonists, and antacids at the
same time.
- People with known G6PD deficiency.
- Pregnant or lactating patients. Women of childbearing potential must have a negative
serum pregnancy test within 14 days of enrollment. Women of childbearing potential
must agree to use effective contraception 14 days before enrollment, throughout
treatment, and for 4 to 6 months after the last dose of study treatment.
- Those with electrogram QTcB > 480 ms within 14 days of enrollment.
- Patients with congestive heart failure NYHA grade III or more severe (physical
activity is significantly limited).
- History of acute coronary syndrome (including myocardial infarction or unstable
angina), coronary angioplasty or stent implantation within 6 months, or current
clinically significant uncontrolled disease recorded by echocardiography History or
evidence of arrhythmias or intracardiac defibrillators or cardiac valve morphological
abnormalities (=Grade 2). Subjects with grade 1 abnormalities (ie, mild
regurgitation/stenosis) are eligible for enrollment. Subjects with moderate valve
thickening were not eligible. Subjects with controlled atrial fibrillation for >30
days prior to dosing were eligible.
- Patients with previous systemic anti-cancer treatment (chemotherapy, immunotherapy,
biological therapy, vaccine treatment within 3 weeks before study treatment, or
chemotherapy without delayed toxicity within 2 weeks before study treatment).
- Any serious or unstable pre-existing illness, mental illness, or other condition that
may affect subject safety, obtaining informed consent, or compliance with research
procedures.
- History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Subjects with
laboratory evidence of cure of HBV and/or HCV will be admitted.
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