Neoadjuvant treatment response in locally advanced thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.