Actively Recruiting
Biochemical, Radiological and Pathological Responses to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer: A Multicenter Study
Led by Fujian Medical University · Updated on 2026-02-19
120
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial studies patients with locally advanced thyroid cancer (LATC), a form of thyroid cancer that invades nearby critical tissues and has a poor outlook. It evaluates the safety and effects of neoadjuvant therapy before surgery by analyzing imaging, biochemical, and pathological responses. Researchers also compare short-term surgical results and long-term outcomes with patients who have surgery upfront. The study further investigates immune cell changes and explores biological markers that may influence tumor resistance and treatment decisions. Participants receive neoadjuvant treatments such as multikinase inhibitors, RET inhibitors, BRAF b1 MEK inhibitors, or combinations including PD-1 inhibitors for at least two cycles before surgery. Others undergo immediate radical surgery based on expert team recommendations and patient choice. Tissue biopsies are performed for detailed tumor analysis. Surgery is done when patients are considered resectable either after therapy or at diagnosis. During the study, participants undergo imaging assessments, pathology evaluations at surgery, and biochemical tests up to a year after surgery. Researchers measure radiographic and pathologic responses, progression-free survival, surgical complication rates, and overall survival up to 24 months. The study includes monitoring for adverse events related to treatments and surgery, with data collected from multiple centers over several years.
CONDITIONS
Brief Title
Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 14 years at enrollment
- ECOG performance status of 0 to 2
- Histologically or cytologically confirmed thyroid carcinoma including DTC, MTC, PDTC, and ATC
- Locally advanced thyroid cancer defined as clinical stage T4N0-1 at baseline confirmed by a multidisciplinary board
- Potential surgical benefit documented for patients with distant metastasis
- At least one measurable lesion per RECIST version 1.1
- Normal major organ function
- Written informed consent obtained
You will not qualify if you...
- Refusal to undergo tumor tissue biopsy or surgery
- Prior thyroid or major neck surgery
- Previous cancer treatments that affect current plan including surgery, chemotherapy, radiotherapy, or targeted therapy
- Concurrent active malignancies
- Uncontrolled systemic diseases such as diabetes or hypertension
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least two treatment cycles prior to surgery
Participants in the neoadjuvant treatment group receive targeted drug therapies, including multikinase inhibitors, BRAF ± MEK inhibitors, RET inhibitors, or combination regimens containing PD-1 inhibitors to shrink tumors before surgery.
Multiple visits during treatment cycles
Duration - Single surgical event with perioperative period
Participants who are considered resectable after neoadjuvant therapy or at baseline undergo radical thyroidectomy as determined by a multidisciplinary team.
1 visit for surgery and immediate perioperative care
Duration - Up to 24 months after surgery
Participants are monitored post-surgery for biochemical responses, surgical complications, disease progression, and survival outcomes up to 24 months.
Regular follow-up visits during 24 months
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
W
Wenxin Zhao, M.D., Ph.D.
Z
Zihan Tang, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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