Ameloblastoma
Conditions
Interventions
Since this study is a single-arm study, it does not involve randomization and blinding, nor does it establish a parallel control group and uses external control:Dabrafenib mesylate capsules drug inter
Sponsors
Stomatological Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Histology confirmed ameloblastoma. (2) The patient was tested positive for BRAF V600E mutation. (3) Eligible patients must have evaluable lesions within the jaw that meet RECIST criteria. (4) Aged 18 or above. (5) Laboratory test results: ANC > 1.5 x 109/L PLT > 99 x 109/L Hemoglobin >8 g/dL Tbili 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. (6) Patients of childbearing potential must agree to use effective contraception for at least 6 months after treatment with dabrafenib. (7) 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. (8) The left ventricular ejection fraction is equal to or greater than normal within 1 month of enrollment. (9) Voluntarily sign the informed consent form and cooperate with the treatment.
Exclusion criteria
Exclusion criteria: (1) Those who have used BRAF inhibitor treatment in the past. (2) 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, and breast cancer Cancer and malignant tumors with confirmed activating RAS mutations at any time. (3) Those who have had retinal vein occlusion in the past or currently. (4) Those with a history of interstitial lung disease or lung inflammation. (5) 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. (6) Patients with previous allergic reactions caused by compounds with similar chemical or biological components to dabrafenib or trametinib. (7) Taking strong CYP3A4 or CYP2C8 inhibitors (such as ketoconazole, nefazodone, clarithromycin, gemfizil) or strong inducers (such as rifampin, phenytoin, carbamazepine, phenobarbide) at the same time appropriate). (8) Those who take proton pump inhibitors, H2 receptor antagonists, and antacids at the same time. (9) People with known G6PD deficiency. (10) 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. (11) Those with electrogram QTcB > 480 ms within 14 days of enrollment. (12) Patients with congestive heart failure NYHA grade III or more severe (physical activity is significantly limited). (13) 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. (14) 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). (15) 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. (16) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival;The changes of tumor cell types, BRAF V600E expression and the spatial distribution of expression region before and after treatment; | — |
Countries
China
Contacts
Public ContactQing Li
School and Hospital of Stomatology, Cheeloo College of Medicine, Shandong University
Outcome results
None listed