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Biochemical, Radiological and Pathological Responses to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer: A Multicenter Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Contact Information
Primary
Wenxin Zhao, M.D., Ph.D.
fzhzwx6688@163.com
+86-591-86218065
Backup
Zihan Tang, M.D.
tzhan2016@163.com
+86-13615083322
Time Frame
Start Date: 2025-12-23
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Fujian Medical University

This content was sourced from clinicaltrials.gov