About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years at enrollment.
Radioactive-iodine-refractory differentiated thyroid carcinoma (DTC)
Medullary thyroid carcinoma (MTC)
Anaplastic or poorly differentiated thyroid carcinoma (ATC/PDTC)
Disqualifiers
Untreated or symptomatic CNS metastases; patients with treated, stable lesions ≥ 4 weeks and off corticosteroids are eligible.
Pregnant or breastfeeding. Women and men of child-bearing potential must agree to effective contraception during study and for ≥ 120 days after last dose (≥ 180 days for men after dabrafenib/trametinib).
Trial design
Treatments tested in this trial
- Dabrafenib
- Trametinib
- Selpercatinib
- Pralsetinib
- Lenvatinib
- Larotrectinib
- Anlotinib
- Pembrolizumab
- Sintilimab
- Cabozantinib
- Bemosuzumab
- Conversion Surgery
Treatment groups
7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Fujian Medical University
Lead sponsor
Fujian Medical University Union Hospital
Sponsor institution