RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 14 years at enrollment. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. - diagnosed by tissue sample (biopsy-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 willing to sign a consent form obtained. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * 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.

Treatments Being Tested

DRUG

Multitarget Tyrosine Kinase Inhibitors

Patients with or without actionable genomic alterations may receive a multikinase inhibitor (e.g., lenvatinib or anlotinib) as neoadjuvant therapy.

DRUG

BRAF inhibitor dabrafenib and MEK inhibitor trametinib

Patients with BRAF V600E mutation may receive combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib.

DRUG

RET Inhibitor

Patients with RET fusion may receive a selective RET inhibitor (e.g., selpercatinib).

DRUG

PD(L)-1 inhibitor

In selected cases, combination regimens incorporating immunotherapy may be considered.

PROCEDURE

Biopsy

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.

PROCEDURE

Surgery

Patients considered resectable after neoadjuvant therapy will undergo definitive surgery, as determined by consensus of the multidisciplinary team (MDT).

PROCEDURE

Surgery

Patients deemed resectable at baseline will undergo immediate surgery based on MDT consensus and informed patient preference.

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China