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Recruiting NCT06195228

A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer

Phase IV Interventional Advanced Thyroid Cancer Patients Who Received Target Therapy

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: dabrafenib plus trametinib with or without PD-1 antibody, entrectinib or larotrectinib with or without anti-PD-1 antibdoy, pralsetinib or selpercatinib with or without anti-PD-1 antibdoy, anlotinib or anlotinib plus anti-PD-1 antibody.
Who it may be relevant to
Registry conditions: Advanced Thyroid Cancer Patients Who Received Target Therapy. Basic parameters: No limits · 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 →

Unsure about the terms? Read our patient guide →

Overview

This is a retrospective and prospective real-world clinical study of molecular typing in the treatment of advanced thyroid cancer. The retrospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 participated hospitals from January 2020 to December 2023 were retrieved. The number of previous treatment lines was not limited. Patients who met the inclusion criteria were screened according to the inclusion and exclusion criteria. Demographic information, clinical characteristics, tumor treatment history, medication regimen, adverse reactions, molecular test results, survival follow-up results and other data were collected. The prospective study : Patients with advanced thyroid cancer who received precise treatment in the 24 Chinese hospitals from January 2024 to April 2027 were enrolled.

Detailed description

see:Arms and Interventions

Interventions

  • Drug dabrafenib plus trametinib with or without PD-1 antibody
    advanced thyroid cancer patients who harbor BRAF V600E mutation
  • Drug entrectinib or larotrectinib with or without anti-PD-1 antibdoy
    advanced thyroid cancer patients who harbor NTRK mutation
  • Drug pralsetinib or selpercatinib with or without anti-PD-1 antibdoy
    advanced thyroid cancer patients who harbor RET fusion or medullary thyroid carcinoma patients who habor RET mutation.
  • Drug anlotinib or anlotinib plus anti-PD-1 antibody
    For patients with medullary carcinoma, if there is no RET gene mutation or RET gene mutation is unknown
  • Drug lenvatinib plus anti-PD-1 antibody
    Advanced thyroid cancer patients who don't harbor the above gene mutation or could not afford the cost of precision treatment even with the above gene mutation
  • Drug Other Targets: precise treatment based on the target
    Advanced thyroid cancer patients who had other treatment targets not included above

Primary outcome measures

  • Objective Response Rate(ORR) [Time frame: up to approximately 3 years]
Secondary outcome measures (5)
  • Duration of Response(DOR) [Time frame: up to approximately 3 years]
  • Disease Control Rate(DCR) [Time frame: up to approximately 3 years]
  • Time to response(TTR) [Time frame: up to approximately 3 years]
  • Progression Free Survival(PFS) [Time frame: up to approximately 3 years]
  • Overall survival(OS) [Time frame: up to approximately 3 years]

Eligibility criteria

Inclusion criteria

  • Patients volunteered to participate in this study and signed informed consent;
  • Each center can be enrolled in patients who meet the age of their own practice range, regardless of gender ;
  • Histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements:
  • Radioiodine-refractory differentiated thyroid cancer (RAIR-DTC);
  • Differentiated thyroid carcinoma not suitable for iodine therapy;
  • Medullary thyroid carcinoma (MTC);
  • poorly differentiated thyroid cancer (PDTC) or anaplastic thyroid cancer (ATC);
  • Thyroid-related pathogenic or therapeutic target gene detection was performed before enrollment.

Exclusion criteria

  • Patients who are participating in clinical trials of other drugs;
  • There is evidence that the patients are pregnant or lactating;
  • Other situations that are not suitable for inclusion in this study.

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

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 8 centers
  • Fujian Cancer Hospital — Fuzhou
  • Henan Cancer Hospital — Zhengzhou
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan
  • Caixia Liu — Hohhot
  • Fudan University Shanghai Cancer Center — Shanghai
  • Shanxi Cancer Hospital — Shanxi
  • Zhejiang Cancer Hospital — Hangzhou
  • Peking union medical college hospital — Beijing

Identifiers

NCT: NCT06195228 · FUSCC-TC-RWS01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗