An observational study in Thyroid Cancer and Thyroid Neoplasms, sponsored by Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Fujian Medical University · Observational
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.
Locally advanced thyroid cancer (LATC) is characterized by tumors that extensively invade critical adjacent structures, leading to a poor prognosis and significantly contributing to thyroid cancer-related mortality. In recent years, neoadjuvant therapy has been increasingly applied to LATC, resulting in tumor downstaging and improved resectability in some patients. However, challenges remain in optimizing radical treatment strategies and improving long-term outcomes for LATC patients.
This study aims to systematically analyze the clinical data of LATC patients who underwent neoadjuvant treatment followed by radical thyroidectomy, with a focus on the following objectives: (1) to summarize the imaging, biochemical, and pathological responses to neoadjuvant therapy and investigate associated recurrence risk stratification; (2) to evaluate the short-term efficacy of surgical outcomes (e.g., R0/R1 resection rates, perioperative complications) and long-term prognosis (e.g., survival outcomes), with comparisons to a control cohort of patients undergoing upfront surgery.
Furthermore, the investigators will examine changes in the profiles and functions of immune cells within tumors, lymph nodes, and peripheral blood after the interventions, and assess their correlation with neoadjuvant response and prognosis. Additionally, based on multi-omics features, including pathological histology, ultrasonomics, bulk RNA sequencing, single-cell RNA sequencing, and spatial transcriptomics, the study aims to identify potential biological markers for tumor resistance mechanisms and explore biomarkers that could inform clinical decision-making.
802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's planned enrollment of 120 is below the median of 172 across 261 observational studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →Fujian Medical University is the lead sponsor of 144 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with LATC may be managed with either neoadjuvant therapy followed by surgery or upfront surgery, depending on resectability and multidisciplinary team assessment.
Exclusion Criteria:
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.
Drug: Multitarget Tyrosine Kinase Inhibitors · Drug: BRAF inhibitor dabrafenib and MEK inhibitor trametinib · Drug: RET Inhibitor · Drug: PD(L)-1 inhibitor · Procedure: Biopsy · Procedure: Surgery
The participants in this group will undergo radical surgery directly after the diagnosis of LATC, based on MDT consensus and patient's preference.
Procedure: Biopsy · Procedure: Surgery
Patients with or without actionable genomic alterations may receive a multikinase inhibitor (e.g., lenvatinib or anlotinib) as neoadjuvant therapy.
Also known as: Lenvatinib, Anlotinib
Patients with BRAF V600E mutation may receive combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib.
Also known as: Dabrafenib, Trametinib
Patients with RET fusion may receive a selective RET inhibitor (e.g., selpercatinib).
Also known as: Selpercatinib, Pralsetinib
In selected cases, combination regimens incorporating immunotherapy may be considered.
Also known as: Pembrolizumab, Nivolumab
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.
Also known as: Core Needle Biopsy, Fine-needle Aspiration
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: From the date of surgery until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Biochemical Response
Serum thyroglobulin (Tg) levels in patients with DTC and serum calcitonin and carcinoembryonic antigen (CEA) levels in patients with MTC will be measured after definitive surgery. Levels will be: 1. compared across subgroups defined by radiographic response (per RECIST v1.1) and pathologic response (e.g., pCR, pPR, pNR) within the neoadjuvant therapy cohort; and 2. compared between the neoadjuvant therapy plus surgery group and the upfront surgery group at matched postoperative timepoints.
Time frame: From 4 weeks to 12 months after surgery.
R0/1 Resection Rate
Percentage of resected participants with no residual tumor (R0) or microscopic residual tumor (R1) on final pathology.
Time frame: At the time of surgery.
Change in Surgical Complexity and Morbidity Score
The MGH/MEE-MSK-MD Anderson Surgical Morbidity Complexity Score (SMCS) will be used to assess surgical complexity. The SCMS is a validated 5-level scale \[mild (level 0), moderate (level 1), severe (level 2), very severe (level 3), and unresectable (level 4)\] that quantifies surgical complexity based on preoperative radiographic assessment of tumor involvement with critical neck structures.、 The SMCS will be collected at enrollment (baseline imaging) and prior to surgery using restaging imaging. The change in SCMS will be reported as the median SCMS value.
Time frame: From baseline to preoperative imaging assessment after neoadjuvant therapy.
Surgery Related Adverse Events
Surgery related adverse events (SRAEs) are defined as complications occurring during surgery or within 30 days postoperatively. Postoperative complications will be documented and classified according to the Clavien-Dindo grading system, including but not limited to hemorrhage, hypoparathyroidism, vocal cord palsy, chyle leakage, and wound infection.
Time frame: During surgery or within 30 days after surgery.
Incidence of Grade ≥ 3 Neoadjuvant Treatment-Related Advert Events
Number and percentage of participants experiencing Grade 3 or higher adverse events, assessed according to CTCAE v5.0.
Time frame: From baseline to 30 days after the last dose of neoadjuvant therapy.
Overall Survival (OS)
Time from surgery to all-cause death, with survivors censored at the date of last follow-up.
Time frame: From the date of surgery to death from any cause, assessed up to 24 months.
Tumor Microenvironment and Immune Profiling
Changes in tumor immune cell composition following neoadjuvant therapy, assessed by single-cell RNA sequencing of tumor tissue obtained at baseline (pre-neoadjuvant biopsy) and at surgery. The outcome measure will be the change in the proportion of major immune cell subsets within the tumor microenvironment.
Time frame: From baseline (pre-neoadjuvant therapy biopsy) to surgery.
Plan to share: No
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Fujian Medical University