Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer

Sponsor
Fujian Medical University
Study ID
NCT07419932
Status
Recruiting
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Conditions

  • Thyroid Cancer
  • Thyroid Neoplasms

Eligibility Criteria

Sex
ALL
Age
14 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Multitarget Tyrosine Kinase Inhibitors — DRUG
    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 trametinib — DRUG
    Patients with BRAF V600E mutation may receive combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib.
  • RET Inhibitor — DRUG
    Patients with RET fusion may receive a selective RET inhibitor (e.g., selpercatinib).
  • PD(L)-1 inhibitor — DRUG
    In selected cases, combination regimens incorporating immunotherapy may be considered.
  • Biopsy — PROCEDURE
    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.
  • Surgery — PROCEDURE
    Patients considered resectable after neoadjuvant therapy will undergo definitive surgery, as determined by consensus of the multidisciplinary team (MDT).
  • Surgery — PROCEDURE
    Patients deemed resectable at baseline will undergo immediate surgery based on MDT consensus and informed patient preference.

Study Details

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.

Key Dates

Start date
Dec 23, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Radiographic Response [ Time Frame: From baseline to preoperative imaging assessment after neoadjuvant therapy. ]

Central Contacts

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