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drugset / Trial / NCT07010393

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

NCT07010393 ↗

Phase 4 Not yet recruiting 335 enrolled Fujian Medical University
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-01
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bemosuzumab Unknown 900 mg Intravenous
Subject Cabozantinib Small molecule 60 mg Oral
Subject Catequentinib Small molecule 12 mg Oral
Subject Dabrafenib Small molecule 150 mg Oral
Subject Larotrectinib Small molecule 100 mg Oral
Subject Lenvatinib Small molecule 20 mg Oral
Subject Lenvatinib Small molecule 24 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pralsetinib Small molecule 400 mg Oral
Subject Selpercatinib Small molecule 160 mg Oral
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject Trametinib Small molecule 2 mg Oral

Indications

thyroid tumor