Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer
Biochemical, Radiological and Pathological Responses to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer: A Multicenter Study
Fujian Medical University
120 participants
Dec 23, 2025
OBSERVATIONAL
Conditions
Summary
This multicenter observational study aims to evaluate the safety and efficacy of neoadjuvant therapy in patients with locally advanced thyroid cancer, focusing on imaging, biochemical, and pathological responses, as well as short-term surgical outcomes and long-term prognosis.
Eligibility
Inclusion Criteria8
- Age ≥ 14 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Histologically or cytologically confirmed thyroid carcinoma, including differentiated thyroid carcinoma (DTC), medullary thyroid carcinoma (MTC), poorly differentiated thyroid carcinoma (PDTC), and anaplastic thyroid carcinoma (ATC).
- LATC defined as clinical stage T4N0-1 at baseline, as confirmed by a multidisciplinary thyroid oncology board.
- For patients with distant metastasis, the potential benefit from surgical intervention must be documented by the treating team.
- Presence of at least one measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Normal function of major organs.
- Written informed consent obtained.
Exclusion Criteria6
- Patients who refuse tumor tissue biopsy or surgery.
- Prior thyroid or major neck surgery.
- History of other treatments for cancer, including surgery, chemotherapy, radiotherapy, or molecular targeted therapy, that may affect the current treatment plan.
- Concurrent active malignancies.
- Uncontrolled systemic diseases, including diabetes, hypertension, etc.
- Pregnancy or breastfeeding.
Interventions
Patients with or without actionable genomic alterations may receive a multikinase inhibitor (e.g., lenvatinib or anlotinib) as neoadjuvant therapy.
Patients with BRAF V600E mutation may receive combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib.
Patients with RET fusion may receive a selective RET inhibitor (e.g., selpercatinib).
In selected cases, combination regimens incorporating immunotherapy may be considered.
While fine-needle aspiration (FNA) is the standard initial diagnostic modality for thyroid nodules, core needle biopsy (CNB) is performed to obtain tissue cores for histological subtyping and molecular profiling in locally advanced cases.
Patients considered resectable after neoadjuvant therapy will undergo definitive surgery, as determined by consensus of the multidisciplinary team (MDT).
Patients deemed resectable at baseline will undergo immediate surgery based on MDT consensus and informed patient preference.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07419932