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NOT YET RECRUITING
NCT07010393
PHASE4

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

Sponsor: Fujian Medical University

View on ClinicalTrials.gov

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

Interventions

DRUG

Dabrafenib

150 mg orally twice daily; ≤4 × 28-day cycles

DRUG

Trametinib

2 mg orally once daily; same duration

DRUG

Selpercatinib

160 mg orally twice daily; ≤4 cycles

DRUG

Pralsetinib

retrospective, 400 mg orally once daily; ≤4 cycles

DRUG

Lenvatinib

24 mg orally once daily; ≤4 cycles

DRUG

Larotrectinib

Larotrectinib 100 mg orally twice daily, continuous 28-day cycles.

DRUG

Anlotinib

12 mg orally once daily; 2 weeks on / 1 week off, ≤4 cycles (alternative)

DRUG

Pembrolizumab

200 mg IV infusion every 3 weeks; ≤4 cycles

DRUG

Sintilimab

200 mg IV infusion every 3 weeks; ≤4 cycles

DRUG

Cabozantinib

Cabozantinib 60 mg orally once daily, continuous 28-day cycles.

DRUG

Bemosuzumab

China PD-L1 antibody bemosuzumab 900 mg IV every 2 weeks (14-day cycle).

PROCEDURE

Conversion Surgery

Conversion Surgery if resectable

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China