RecruitingPhase 4NCT06195228

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


Sponsor

Fudan University

Enrollment

800 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria8

  • 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 Criteria3

  • 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.

Interventions

DRUGdabrafenib plus trametinib with or without PD-1 antibody

advanced thyroid cancer patients who harbor BRAF V600E mutation

DRUGentrectinib or larotrectinib with or without anti-PD-1 antibdoy

advanced thyroid cancer patients who harbor NTRK mutation

DRUGpralsetinib 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.

DRUGanlotinib 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

DRUGlenvatinib 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

DRUGOther Targets: precise treatment based on the target

Advanced thyroid cancer patients who had other treatment targets not included above


Locations(8)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Caixia Liu

Hohhot, Inner Mongolia, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Shanxi, Taiyuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Peking union medical college hospital

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT06195228