Ameloblastoma
Conditions
Interventions
Treatment Group:Conservative Surgery Combined with Dabrafenib/Trametinib Treatment
Sponsors
Hospital of Stomatology, SunYat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years; 2. Histologically confirmed diagnosis of classical (cystic/solid) ameloblastoma, and confirmed presence of BRAFV600E mutation by next-generation sequencing (NGS); 3. Patient is assessed at initial diagnosis as requiring segmental mandibular resection, and the surgical indication is confirmed independently by at least two chief physicians in the department; 4. No evidence of distant metastasis or malignant transformation; 5. ECOG performance status of 0–1; 6. Willing to undergo conservative surgery combined with Dabrafenib/Trametinib therapy; 7. No known contraindications to MEK or BRAF inhibitors; 8. Adequate function of major organs, meeting the following criteria: a) Hematologic parameters: WBC >= 4.0 × 10?/L, ANC >= 1.5 × 10?/L, PLT >= 100 × 10?/L, Hb >= 90 g/L (with no transfusion, blood products, or hematopoietic stimulants such as G-CSF within the past 14 days); b) Biochemical parameters: serum albumin >= 3.0 g/dL (30 g/L), TBIL = 60 ml/min (by Cockcroft-Gault formula); c) Coagulation: INR or PT <= 1.5×ULN; for subjects on anticoagulation therapy, PT must be within the therapeutic range defined by the medication; 9. Women of childbearing potential must use reliable contraception, test negative on a pregnancy test within 7 days prior to enrollment, and agree to use effective contraception during the study and for 16 weeks after the last dose of trametinib/dabrafenib. Male participants with partners of childbearing potential must also agree to use effective contraception during the study and for 16 weeks after the last dose; 10. Articipant voluntarily agrees to join the study, signs the informed consent form, has good compliance, and is willing to undergo follow-up assessments;
Exclusion criteria
Exclusion criteria: 1. Patients who have previously been treated with Dabrafenib, Trametinib, or any other BRAF or MEK inhibitors. 2. Presence of active autoimmune disease. 3. Patients with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B (defined as HBV DNA >= 104 copies/mL), or active hepatitis C (defined as positive HCV antibody and HCV RNA levels exceeding the lower limit of quantification); 4. Known hypersensitivity to the investigational drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies or targeted therapies. 5. Within 6 months prior to enrollment, the patient experienced any of the following: myocardial infarction, severe or unstable angina, heart failure of NYHA class II or higher, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure; 6. Receipt of a live vaccine within 4 weeks prior to the first dose of the investigational drug is not permitted. Inactivated influenza vaccines administered via injection are allowed; however, live attenuated influenza vaccines administered intranasally are not permitted. 7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 8. Known history of abuse or drug use of psychotropic substances; 9. Pregnant or breastfeeding women. 10. Diagnosis of any other malignancy within 5 years prior to study entry, except for those that have been treated with curative intent and show no evidence of disease, such as adequately treated basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and benign tumors. 11. Presence of other serious physical or psychiatric disorders, or laboratory abnormalities that may increase the risk associated with study participation, interfere with the interpretation of study results, or, in the opinion of the investigator, make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) of BRAFV600E-mutant Ameloblastoma;Mandibular preservation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Regeneration Rate, BRR;Local Recurrence-Free Survival, LRFS;radiological response;pathological response;Adverse reactions and safety of drugs; | — |
Countries
China
Contacts
Public ContactWang Cheng
Hospital of Stomatology, SunYat-sen University
Outcome results
None listed