Neoadjuvant treatment response in locally advanced thyroid cancer
Biochemical, Radiological and Pathological Responses to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer: A Multicenter Study
This study will test whether neoadjuvant therapies can safely shrink locally advanced thyroid cancers and improve surgical outcomes for patients who then undergo thyroidectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | Fujian Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07419932 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study collects clinical data from patients with locally advanced thyroid cancer treated with neoadjuvant therapies followed by radical thyroidectomy and compares outcomes to a control cohort undergoing upfront surgery. It records imaging, biochemical, and pathological responses, short-term surgical endpoints such as R0/R1 resection rates and perioperative complications, and long-term outcomes including recurrence and survival. The protocol includes immune-cell profiling of tumor, lymph node, and peripheral blood samples and multi-omics analyses (histology, ultrasonomics, bulk and single-cell RNA sequencing, and spatial transcriptomics) to identify biomarkers associated with response and prognosis. Treatments available in the cohort include targeted agents (multi-target TKIs, BRAF/MEK, RET inhibitors), PD-(L)1 inhibitors, and biopsy sampling as per treating teams, with standardized data collection across sites.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 or older with histologically confirmed locally advanced (clinical T4N0-1) thyroid cancer who have ECOG 0-2, normal major organ function, measurable disease, and are planned for neoadjuvant therapy followed by surgery.
Not a fit: Patients who refuse biopsy or surgery, have prior major neck surgery or prior cancer treatments, or have inadequate organ function are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could help identify which neoadjuvant treatments improve resectability and long-term outcomes and guide more personalized preoperative therapy.
How similar studies have performed: Smaller series and case reports have shown tumor downstaging with targeted neoadjuvant agents in thyroid cancer, but large systematic studies in locally advanced cases are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Wenxin Zhao, M.D., Ph.D.
- Email: fzhzwx6688@163.com
- Phone: +86-591-86218065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.