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Recruiting NCT07419932

Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer

— Observational Thyroid Cancer Thyroid Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multitarget Tyrosine Kinase Inhibitors, BRAF inhibitor dabrafenib and MEK inhibitor trametinib, RET Inhibitor, PD(L)-1 inhibitor.
Who it may be relevant to
Registry conditions: Thyroid Cancer, Thyroid Neoplasms. Basic parameters: 14 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

Locally advanced thyroid cancer (LATC) is characterized by tumors that extensively invade critical adjacent structures, leading to a poor prognosis and significantly contributing to thyroid cancer-related mortality. In recent years, neoadjuvant therapy has been increasingly applied to LATC, resulting in tumor downstaging and improved resectability in some patients. However, challenges remain in optimizing radical treatment strategies and improving long-term outcomes for LATC patients.

This study aims to systematically analyze the clinical data of LATC patients who underwent neoadjuvant treatment followed by radical thyroidectomy, with a focus on the following objectives: (1) to summarize the imaging, biochemical, and pathological responses to neoadjuvant therapy and investigate associated recurrence risk stratification; (2) to evaluate the short-term efficacy of surgical outcomes (e.g., R0/R1 resection rates, perioperative complications) and long-term prognosis (e.g., survival outcomes), with comparisons to a control cohort of patients undergoing upfront surgery.

Furthermore, the investigators will examine changes in the profiles and functions of immune cells within tumors, lymph nodes, and peripheral blood after the interventions, and assess their correlation with neoadjuvant response and prognosis. Additionally, based on multi-omics features, including pathological histology, ultrasonomics, bulk RNA sequencing, single-cell RNA sequencing, and spatial transcriptomics, the study aims to identify potential biological markers for tumor resistance mechanisms and explore biomarkers that could inform clinical decision-making.

Interventions

  • Drug Multitarget Tyrosine Kinase Inhibitors
    Patients with or without actionable genomic alterations may receive a multikinase inhibitor (e.g., lenvatinib or anlotinib) as neoadjuvant therapy.
  • Drug 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.
  • Drug RET Inhibitor
    Patients with RET fusion may receive a selective RET inhibitor (e.g., selpercatinib).
  • Drug PD(L)-1 inhibitor
    In selected cases, combination regimens incorporating immunotherapy may be considered.
  • Procedure 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.
  • Procedure Surgery
    Patients considered resectable after neoadjuvant therapy will undergo definitive surgery, as determined by consensus of the multidisciplinary team (MDT).
  • Procedure Surgery
    Patients deemed resectable at baseline will undergo immediate surgery based on MDT consensus and informed patient preference.

Primary outcome measures

  • Radiographic Response [Time frame: From baseline to preoperative imaging assessment after neoadjuvant therapy.]
  • Pathologic Response [Time frame: At the time of surgery, based on postoperative pathological evaluation.]
  • Progression-Free Survival (PFS) [Time frame: From the date of surgery until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.]
Secondary outcome measures (6)
  • Biochemical Response [Time frame: From 4 weeks to 12 months after surgery.]
  • R0/1 Resection Rate [Time frame: At the time of surgery.]
  • Change in Surgical Complexity and Morbidity Score [Time frame: From baseline to preoperative imaging assessment after neoadjuvant therapy.]
  • Surgery Related Adverse Events [Time frame: During surgery or within 30 days after surgery.]
  • Incidence of Grade ≥ 3 Neoadjuvant Treatment-Related Advert Events [Time frame: From baseline to 30 days after the last dose of neoadjuvant therapy.]
  • Overall Survival (OS) [Time frame: From the date of surgery to death from any cause, assessed up to 24 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Fujian Medical University Union Hospital — Fuzhou

Identifiers

NCT: NCT07419932 · FMUUH-LACTCS002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗