Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06195228

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Thyroid Cancer Patients Who Received Target Therapy

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fujian Cancer Hospital, Fuzhou, Fujian, China

Loading trial locations.

About this study

see:Arms and Interventions

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dabrafenib plus trametinib with or without PD-1 antibody

Drug

advanced thyroid cancer patients who harbor BRAF V600E mutation

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

Drug

advanced thyroid cancer patients who harbor NTRK mutation

pralsetinib or selpercatinib with or without anti-PD-1 antibdoy

Drug

advanced thyroid cancer patients who harbor RET fusion or medullary thyroid carcinoma patients who habor RET mutation.

anlotinib or anlotinib plus anti-PD-1 antibody

Drug

For patients with medullary carcinoma, if there is no RET gene mutation or RET gene mutation is unknown

lenvatinib plus anti-PD-1 antibody

Drug

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

Other Targets: precise treatment based on the target

Drug

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

Primary outcomes

  1. Objective Response Rate(ORR)

    Time frame: up to approximately 3 years

    Complete remission rate+ partial remission rate

Secondary outcomes

  1. Duration of Response(DOR)

    Time frame: up to approximately 3 years

    Time from the date of first partial remission or complete remission to the date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.

  2. Disease Control Rate(DCR)

    Time frame: up to approximately 3 years

    Complete remission rate+ partial remission rate+stable disease rate

  3. Time to response(TTR)

    Time frame: up to approximately 3 years

    Time from the initiation of the treatment to the first remission

  4. Progression Free Survival(PFS)

    Time frame: up to approximately 3 years

    Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.

  5. Overall survival(OS)

    Time frame: up to approximately 3 years

    Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.

Study contacts

Contact information is provided by the study sponsor or research team.

Dongmei Ji, M.D

CONTACT

[email protected]

021-64175590 ext. 83650

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Changhai Hospital
  • Dalian Friendship Hospital Affiliated to Dalian Medical University
  • Fujian Cancer Hospital
  • Henan Cancer Hospital
  • Hunan Provincial People's Hospital
  • Jiangsu Cancer Institute & Hospital
  • Liaoning Cancer Hospital & Institute
  • Peking Union Medical College Hospital
  • Ruijin Hospital
  • Shanghai 10th People's Hospital
  • Shanghai 6th People's Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
  • Shanxi Province Cancer Hospital
  • Sir Run Run Shaw Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Sun Yat-sen University
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The First Affiliated Hospital of Anhui University of Chinese Medicine
  • The Third Affiliated Hospital of Soochow University
  • Tianjin Medical University Cancer Institute and Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Zhejiang Cancer Hospital

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Jan 8, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.