Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer
NeoLATC
Biochemical, Radiological and Pathological Responses to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer: A Multicenter Study
1 other identifier
observational
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 23, 2025
CompletedFirst Submitted
Initial submission to the registry
February 6, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
February 19, 2026
February 1, 2026
3 years
February 6, 2026
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Radiographic Response
Radiographic response of tumors and lymph nodes to neoadjuvant treatment will be assessed using contrast-enhanced computed tomography (CT) and defined by RECIST v1.1. Complete Response (CR) is defined as disappearance of all target lesions. Partial response (PR) is defined as ≥30% decrease in the sum of the longest diameter of target lesion; progressive disease (PD) as ≥20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is defined as \<20% increase and \<30% decrease in the sum of the longest diameter of target lesions. The objective response rate (ORR) will be calculated as the proportion of patients achieving CR or PR.
From baseline to preoperative imaging assessment after neoadjuvant therapy.
Pathologic Response
Pathologic response in resected tumors and lymph nodes will be assessed on hematoxylin and eosin (H\&E)-stained slides of the entire tumor bed and all sampled lymph nodes. All slides will be digitally scanned and independently reviewed by two pathologists. Pathological complete response (pCR) is defined as the absence of viable tumor cells in all examined slides. For this study, pathological partial response (pPR) is defined as \<50% viable residual tumor, and pathological non-response (pNR) as ≥50% viable residual tumor in the resected specimen.
At the time of surgery, based on postoperative pathological evaluation.
Progression-Free Survival (PFS)
Time from surgery to the earliest date of disease progression or all-cause death.
From the date of surgery until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Secondary Outcomes (6)
Biochemical Response
From 4 weeks to 12 months after surgery.
R0/1 Resection Rate
At the time of surgery.
Change in Surgical Complexity and Morbidity Score
From baseline to preoperative imaging assessment after neoadjuvant therapy.
Surgery Related Adverse Events
During surgery or within 30 days after surgery.
Incidence of Grade ≥ 3 Neoadjuvant Treatment-Related Advert Events
From baseline to 30 days after the last dose of neoadjuvant therapy.
- +1 more secondary outcomes
Other Outcomes (1)
Tumor Microenvironment and Immune Profiling
From baseline (pre-neoadjuvant therapy biopsy) to surgery.
Study Arms (2)
Neoadjuvant Treatment Group
Participants will undergo neoadjuvant treatment with multikinase inhibitors (mTKIs), specific receptor inhibitors (including RET inhibitors or BRAF ± MEK inhibitors), or combination regimens containing a PD-1 inhibitor. All regimens will be administered for at least two cycles prior to surgery.
Upfront Surgery Group
The participants in this group will undergo radical surgery directly after the diagnosis of LATC, based on MDT consensus and patient's preference.
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).
Eligibility Criteria
Patients diagnosed with LATC may be managed with either neoadjuvant therapy followed by surgery or upfront surgery, depending on resectability and multidisciplinary team assessment.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Biospecimen
Fresh tumor specimens will be prospectively collected from patients with locally advanced thyroid cancer (LATC) enrolled in this study after written informed consent is obtained. These specimens include tumor tissue obtained by core needle biopsy prior to neoadjuvant therapy, as well as matched fresh tumor tissue and adjacent non-tumor tissue collected during subsequent surgical resection.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chief Surgeon, Department of Thyroid Surgery
Study Record Dates
First Submitted
February 6, 2026
First Posted
February 19, 2026
Study Start
December 23, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share