NCT06653517 Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
| NCT ID | NCT06653517 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
| Condition | Ameloblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 12 participants in total. It began in 2023-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-65 years; 2. Diagnosed with solid/multicystic type ameloblastoma with confirmed BRAF V600E mutation by next-generation sequencing (NGS); 3. Requires mandibular segmental resection at diagnosis, confirmed by two or more chief physicians; 4. No distant metastasis or malignancy; 5. ECOG score 0-1; 6. Willing to undergo surgery after induction therapy; 7. No significant contraindications to MEK and BRAF inhibitors; 8. Major organ function meets the following standards: 1. Hematological: WBC ≥ 4.0×10\^9/L, ANC ≥ 1.5×10\^9/L, PLT ≥ 100×10\^9/L, Hb ≥ 90g/L (no transfusion or blood products, no use of G-CSF or other hematopoietic stimulants within 14 days); 2. Biochemical: Serum albumin ≥ 3.0 g/dL, TBIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, BUN/CRE ≤ 1.5×ULN or creatinine clearance rate ≥ 60 ml/min; 3. Coagulation: INR or PT ≤ 1.5×ULN (anticoagulant-treated subjects must have PT within the intended range); 9. Women of childbearing age must use effective contraception, have a negative pregnancy test within 7 days before enrollment, and agree to use effective contraception during the study and for 16 weeks after the last dose of trametinib and dabrafenib. Male subjects with partners of childbearing age must use effective contraception during the study and for 16 weeks after the last dose of trametinib and dabrafenib. 10. Voluntary participation with signed informed consent, good compliance, and cooperation for follow-up. Exclusion Criteria: 1. Previous use of dabrafenib, trametinib, or other BRAF/MEK inhibitors; 2. Active autoimmune diseases (stable conditions not requiring systemic immunosuppression allowed); 3. Congenital or acquired immunodeficiency (e.g., HIV), active hepatitis B (HBV-DNA ≥ 10\^4 copies/ml), or hepatitis C (positive HCV antibody and HCR-RNA above the detection limit); 4. Known allergy to study drugs or their excipients, or severe allergic reactions to other monoclonal antibodies or targeted drugs; 5. Myocardial infarction, severe/unstable angina, NYHA class II or higher heart failure, significant arrhythmias, or symptomatic congestive heart failure within 6 months before enrollment; 6. Live vaccination within 4 weeks before the first dose of study drugs (inactivated virus vaccines allowed for seasonal flu, but live attenuated intranasal vaccines not allowed); 7. History of allogeneic organ or hematopoietic stem cell transplantation; 8. Known history of substance abuse or drug addiction; 9. Pregnant or breastfeeding women; 10. Diagnosed with any other tumors within 5 years before the study, except for locally treatable and cured basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ, papillary thyroid carcinoma, and benign tumors; 11. Other severe physical or mental diseases or laboratory abnormalities that may increase the risk of participation or interfere with study results, deemed unsuitable for participation by the investigator.
Contact & Investigator
CAO Wei, PHD;MD
PRINCIPAL INVESTIGATOR
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Frequently Asked Questions
Who can join the NCT06653517 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Ameloblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06653517 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06653517 currently recruiting?
Yes, NCT06653517 is actively recruiting participants. Contact the research team at zaidezaidezz@hotmail.com for enrollment information.
Where is the NCT06653517 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06653517 clinical trial?
NCT06653517 is sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. The principal investigator is CAO Wei, PHD;MD at Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. The trial plans to enroll 12 participants.