Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFujian Medical University

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

335 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Fujian Medical University

Lead sponsor

Fujian Medical University Union Hospital

Sponsor institution