Thyroid CancerNeoLATCNCT07419932
Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer
An observational study of Thyroid Cancer and Thyroid Neoplasms, run by Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Thyroid Cancer, Thyroid Neoplasms
- What is being tested?
- Multitarget Tyrosine Kinase Inhibitors, BRAF inhibitor dabrafenib and MEK inhibitor trametinib and RET Inhibitor
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2025to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with LATC may be managed with either neoadjuvant therapy followed by surgery or upfront surgery, depending on resectability and multidisciplinary team assessment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Wenxin Zhao, M.D., Ph.D., +86-591-86218065, fzhzwx6688@163.com
About this study
Official title: Biochemical, Radiological and Pathological Responses to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer: A Multicenter Study
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.
Read the detailed description
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.
- Conditions
- Thyroid Cancer, Thyroid Neoplasms
- Being tested
- Multitarget Tyrosine Kinase Inhibitors, BRAF inhibitor dabrafenib and MEK inhibitor trametinib, RET Inhibitor, PD(L)-1 inhibitor, Biopsy
- Keywords
- Thyroid Cancer, locally advanced, Neoadjuvant Therapy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multitarget Tyrosine Kinase InhibitorsDrug
Also called Lenvatinib, Anlotinib
Patients with or without actionable genomic alterations may receive a multikinase inhibitor (e.g., lenvatinib or anlotinib) as neoadjuvant therapy.
BRAF inhibitor dabrafenib and MEK inhibitor trametinibDrug
Also called Dabrafenib, Trametinib
Patients with BRAF V600E mutation may receive combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib.
RET InhibitorDrug
Also called Selpercatinib, Pralsetinib
Patients with RET fusion may receive a selective RET inhibitor (e.g., selpercatinib).
PD(L)-1 inhibitorDrug
Also called Pembrolizumab, Nivolumab
In selected cases, combination regimens incorporating immunotherapy may be considered.
BiopsyProcedure or surgery
Also called Core Needle Biopsy, Fine-needle Aspiration
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.
SurgeryProcedure or surgery
Patients considered resectable after neoadjuvant therapy will undergo definitive surgery, as determined by consensus of the multidisciplinary team (MDT).
SurgeryProcedure or surgery
Patients deemed resectable at baseline will undergo immediate surgery based on MDT consensus and informed patient preference.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 | |
| 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. Receives: Procedure: Biopsy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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:
- 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
- compared between the neoadjuvant therapy plus surgery group and the upfront surgery group at matched postoperative timepoints.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the date of surgery to death from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start23 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wenxin zhao, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419932
- Sponsor's protocol ID
- FMUUH-LACTCS002
- Acronym
- NeoLATC
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical, Radiological and Pathological Responses to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07419932
- Acronym / sponsor ID
- NeoLATC / FMUUH-LACTCS002
- Conditions
- Thyroid Cancer, Thyroid Neoplasms
- Keywords
- Thyroid Cancer, locally advanced, Neoadjuvant Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Treatment Group | – | Drug: Multitarget Tyrosine Kinase Inhibitors, Drug: BRAF inhibitor dabrafenib and MEK inhibitor trametinib, Drug: RET Inhibitor, Drug: PD(L)-1 inhibitor, Procedure: Biopsy, Procedure: SurgeryParticipants 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 | – | Procedure: Biopsy, Procedure: SurgeryThe participants in this group will undergo radical surgery directly after the diagnosis of LATC, based on MDT consensus and patient's preference. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with LATC may be managed with either neoadjuvant therapy followed by surgery or upfront surgery, depending on resectability and multidisciplinary team assessment.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multitarget Tyrosine Kinase InhibitorsAlso: Lenvatinib, AnlotinibPatients with or without actionable genomic alterations may receive a multikinase inhibitor (e.g., lenvatinib or anlotinib) as neoadjuvant therapy. | Drug | Neoadjuvant Treatment Group |
| BRAF inhibitor dabrafenib and MEK inhibitor trametinibAlso: Dabrafenib, TrametinibPatients with BRAF V600E mutation may receive combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib. | Drug | Neoadjuvant Treatment Group |
| RET InhibitorAlso: Selpercatinib, PralsetinibPatients with RET fusion may receive a selective RET inhibitor (e.g., selpercatinib). | Drug | Neoadjuvant Treatment Group |
| PD(L)-1 inhibitorAlso: Pembrolizumab, NivolumabIn selected cases, combination regimens incorporating immunotherapy may be considered. | Drug | Neoadjuvant Treatment Group |
| BiopsyAlso: Core Needle Biopsy, Fine-needle AspirationWhile 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 or surgery | Neoadjuvant Treatment Group, Upfront Surgery Group |
| SurgeryPatients considered resectable after neoadjuvant therapy will undergo definitive surgery, as determined by consensus of the multidisciplinary team (MDT). | Procedure or surgery | Neoadjuvant Treatment Group |
| SurgeryPatients deemed resectable at baseline will undergo immediate surgery based on MDT consensus and informed patient preference. | Procedure or surgery | Upfront Surgery Group |
Primary outcome
Radiographic Response
Time frame: From baseline to preoperative imaging assessment after neoadjuvant therapy.
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.
Pathologic Response
Time frame: At the time of surgery, based on postoperative pathological evaluation.
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.
Progression-Free Survival (PFS)
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.
Time from surgery to the earliest date of disease progression or all-cause death.
6 secondary outcomes
Biochemical Response
Time frame: From 4 weeks to 12 months after surgery.
R0/1 Resection Rate
Time frame: At the time of surgery.
Change in Surgical Complexity and Morbidity Score
Time frame: From baseline to preoperative imaging assessment after neoadjuvant therapy.
Surgery Related Adverse Events
Time frame: During surgery or within 30 days after surgery.
Incidence of Grade ≥ 3 Neoadjuvant Treatment-Related Advert Events
Time frame: From baseline to 30 days after the last dose of neoadjuvant therapy.
Overall Survival (OS)
Time frame: From the date of surgery to death from any cause, assessed up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Thyroid Neoplasms, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenxin Zhao, M.D., Ph.D. (+86-591-86218065, fzhzwx6688@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Response (time frame: From baseline to preoperative imaging assessment after neoadjuvant therapy.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.