Status:

RECRUITING

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

Lead Sponsor:

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Conditions:

Ameloblastoma

BRAF V600E Mutation Positive

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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 mu...

Detailed Description

PRIMARY OBJECTIVES: Ⅰ. To observe the proportion of patients with ameloblastoma requiring mandibular segmental resection at initial diagnosis who can convert to mandibular preservation surgery after ...

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.

Key Trial Info

Start Date :

January 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2029

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT06653517

Start Date

January 1 2023

End Date

December 31 2029

Last Update

October 22 2024

Active Locations (1)

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Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200011

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma | DecenTrialz