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Dabrafenib

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This study is a single-arm study that does not involve randomization or blinding, nor does it establish a parallel control group and uses external control.

Generic name: Dabrafenib mesylate capsules Dosage form: capsule Specifications: 50mg, calculated as C23H20F3N5O2S2 Usage: Orally The dose of dabrafenib is 150 mg twice daily (equivalent to a total daily dose of 300 mg), taken at least 1 hour before or 2 hours after a meal. If you miss a dose and it is less than 6 hours before the next dose, you should not take it.

Patients who undergo fenestrated decompression will be administered the drug for 8 weeks, with curettage performed between weeks 8 and 9. Patients undergoing curettage will continue to take dabrafenib preoperatively until a few hours before surgery, but ideally, patients will take dabrafenib within 12 hours before surgery.

Baihui Miao

Qing Li

This pilot clinical trial plans to carry out dabrafenib adjuvant therapy combined with lesion curettage after fenestrated decompressive surgery for BRAF mutation-positive multicystic ameloblastoma to explore the effectiveness of this therapy in preventing tumor recurrence, reducing or even avoiding postoperative deformity and dysfunction. effect. Based on this, we plan to launch a prospective clinical study of dabrafenib in the treatment of BRAF V600E ameloblastoma, verify the feasibility of drug treatment or drug-assisted treatment of ameloblastoma, and provide patients with a safer Effective new treatment options will benefit more patients.

Main purpose:

To verify the application value of dabrafenib, a targeted drug targeting BRAF V600E mutation, combined with fenestration decompression and tumor curettage therapy in the treatment of multicystic ameloblastoma. It is expected to provide patients with a new treatment option that improves curative effect, reduces postoperative tumor recurrence, and avoids postoperative deformity.

Secondary purpose:

Study of regional heterogeneity in BRAF V600E-mutant ameloblastoma. Provide new ideas for finding other effective treatments.

Overall research design This study is a single-center, single-arm exploratory study. It is planned to enroll 10 patients with BRAF V600E mutation-positive multicystic ameloblastoma. After signing the informed consent form, you can enter the study as a subject.

Subjects will receive the study drug dabrafenib immediately after window decompression surgery. They will take dabrafenib for at least 8 weeks. Lesion curettage will be performed within the 8th to 9th week. Preoperative imaging will check the tumor volume. zoomed out situation. Patients whose lesions are not completely curettaged may choose to resume the dose of dabrafenib they received immediately before surgery.

Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma

It is defined as the proportion of patients whose tumor volume has been reduced by 40% between treatment after fenestration decompression and before curettage, that is, the sum of the proportions of complete response (CR) and partial response (PR).

The time from tumor curettage to disease recurrence (local, regional or distant metastasis), whichever occurs first, is determined according to the investigator's assessment.

Shandong University

graduate student

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma	NCT06264778	Ameloblastoma	Dabrafenib	18 Years - 65 Years	Shandong University
Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma	NCT06264778	Ameloblastoma	Dabrafenib	18 Years - 65 Years	Shandong University

Spots Global Cancer Trial Database for fenestration decompression