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Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study
Sponsor: Fujian Medical University
Summary
This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion/mutation, isolated TERT mutation, triple-negative BRAF/RET/TERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0/1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.
Official title: A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
335
Start Date
2025-07-01
Completion Date
2028-12-31
Last Updated
2025-06-08
Healthy Volunteers
No
Conditions
Interventions
Dabrafenib
150 mg orally twice daily; ≤4 × 28-day cycles
Trametinib
2 mg orally once daily; same duration
Selpercatinib
160 mg orally twice daily; ≤4 cycles
Pralsetinib
retrospective, 400 mg orally once daily; ≤4 cycles
Lenvatinib
24 mg orally once daily; ≤4 cycles
Larotrectinib
Larotrectinib 100 mg orally twice daily, continuous 28-day cycles.
Anlotinib
12 mg orally once daily; 2 weeks on / 1 week off, ≤4 cycles (alternative)
Pembrolizumab
200 mg IV infusion every 3 weeks; ≤4 cycles
Sintilimab
200 mg IV infusion every 3 weeks; ≤4 cycles
Cabozantinib
Cabozantinib 60 mg orally once daily, continuous 28-day cycles.
Bemosuzumab
China PD-L1 antibody bemosuzumab 900 mg IV every 2 weeks (14-day cycle).
Conversion Surgery
Conversion Surgery if resectable
Locations (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China