Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Multitarget Tyrosine Kinase Inhibitors: 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: Patients with BRAF V600E mutation may receive combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib.

RET Inhibitor: Patients with RET fusion may receive a selective RET inhibitor (e.g., selpercatinib).

PD(L)-1 inhibitor: In selected cases, combination regimens incorporating immunotherapy may be considered.

Biopsy: 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: Patients considered resectable after neoadjuvant therapy will undergo definitive surgery, as determined by consensus of the multidisciplinary team (MDT).

Surgery: Patients deemed resectable at baseline will undergo immediate surgery based on MDT consensus and informed patient preference.

Study 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

Primary outcome measure(s)

• Radiographic Response — From baseline to preoperative imaging assessment after neoadjuvant therapy.
  Radiographic response of tumors and lymph nodes to neoadjuvant treatment will be assessed using contrast-enhanced computed tomography (CT) and defined by RECIST v1.1. Complete Response (CR) is defined as disappearance of all target lesions. Partial response (PR) is defined as ≥30% decrease in the sum of the longest diameter of target lesion; progressive disease (PD) as ≥20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is defined as \<20% increase and \<30% decrease in the sum of the longest diameter of target lesions. The objective response rate (ORR) will be calculated as the proportion of patients achieving CR or PR.
• Pathologic Response — At the time of surgery, based on postoperative pathological evaluation.
  Pathologic response in resected tumors and lymph nodes will be assessed on hematoxylin and eosin (H\&E)-stained slides of the entire tumor bed and all sampled lymph nodes. All slides will be digitally scanned and independently reviewed by two pathologists. Pathological complete response (pCR) is defined as the absence of viable tumor cells in all examined slides. For this study, pathological partial response (pPR) is defined as \<50% viable residual tumor, and pathological non-response (pNR) as ≥50% viable residual tumor in the resected specimen.
• Progression-Free Survival (PFS) — From the date of surgery until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
  Time from surgery to the earliest date of disease progression or all-cause death.

Trial sites (1)

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