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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Thyroid Cancer Patients Who Received Target Therapy
• Intervention / Treatment: Drug: anlotinib or anlotinib plus anti-PD-1 antibody; Drug: Other Targets: precise treatment based on the target; Drug: dabrafenib plus trametinib with or without PD-1 antibody; Drug: entrectinib or larotrectinib with or without anti-PD-1 antibdoy; Drug: pralsetinib or selpercatinib with or without anti-PD-1 antibdoy; Drug: lenvatinib plus anti-PD-1 antibody

Detailed Description

see:Arms and Interventions

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dongmei Ji, M.D; Phone Number: 83650 021-64175590; Email: jidongmei2000@hotmail.com

Study Locations

• China
  • Beijing, China, 100000
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Yansong Lin, M.D.; Phone Number: (010)69156699; Email: linyansong1968@163.com
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: Yu Wu, M.D; Phone Number: 13705003480; Email: headandneck2018@126.com
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Jianwu Qin, M.D; Phone Number: 13598802366; Email: qinjianwu62@163.com
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Contact: Wei Cao, M.D; Phone Number: 13995658573; Email: caowei@hust.edu.cn
      • Principal Investigator: Wei Cao
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010000
      • Recruiting
      • Caixia Liu
      • Contact: Caixia Liu, M.D; Phone Number: 18847189559; Email: lcxzhg1974@163.com
      • Contact: M.D
      • Principal Investigator: Caixia Liu, M.D
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Dongmei Ji, M.D; Phone Number: 73546 +8602164175590; Email: jidongmei2000@126.com
  • Taiyuan
    • Shanxi, Taiyuan, China, 030000
      • Recruiting
      • Shanxi Cancer Hospital
      • Contact: Linzi Jia, M.D; Phone Number: 15035162908; Email: jialz2008@163.com
      • Principal Investigator: Jia Linzi, M.D
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Meiyu Fang, M.D; Phone Number: 13750851650; Email: fangmy@zjcc.org.cn
      • Contact: Liang Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients volunteered to participate in this study and signed informed consent;
2. Each center can be enrolled in patients who meet the age of their own practice range, regardless of gender ;

3. Histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements:

   1. Radioiodine-refractory differentiated thyroid cancer (RAIR-DTC);
   2. Differentiated thyroid carcinoma not suitable for iodine therapy;
   3. Medullary thyroid carcinoma (MTC);
   4. poorly differentiated thyroid cancer (PDTC) or anaplastic thyroid cancer (ATC);
4. Thyroid-related pathogenic or therapeutic target gene detection was performed before enrollment.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radioiodine-refractory differentiated thyroid cancer; advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment	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: Other Targets: precise treatment based on the target; Advanced thyroid cancer patients who had other treatment targets not included above; 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: 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
Experimental: Differentiated thyroid carcinoma not suitable for radioiodine therapy; advanced or metastatic differentiated thyroid cancer patients who are not suitable for radio iodine therapy, for example, DTC patients with huge neck tumor but cannot receive the thyroid ectomy	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: Other Targets: precise treatment based on the target; Advanced thyroid cancer patients who had other treatment targets not included above; 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: 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
Experimental: Medullary thyroid cancer; patients with advanced or metastatic medullary thyroid cancer	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: Other Targets: precise treatment based on the target; Advanced thyroid cancer patients who had other treatment targets not included above; 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: 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
Experimental: High-grade or poorly differentiated thyroid cancer; patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer	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: Other Targets: precise treatment based on the target; Advanced thyroid cancer patients who had other treatment targets not included above; 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: 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
Experimental: Anaplastic thyroid cancer; patients with anaplastic thyroid cancer	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: Other Targets: precise treatment based on the target; Advanced thyroid cancer patients who had other treatment targets not included above; 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate(ORR)	Complete remission rate+ partial remission rate	up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response(DOR)	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.	up to approximately 3 years
Progression Free Survival(PFS)	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.	up to approximately 3 years
Overall survival(OS)	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.	up to approximately 3 years
Disease Control Rate(DCR)	Complete remission rate+ partial remission rate+stable disease rate	up to approximately 3 years
Time to response(TTR)	Time from the initiation of the treatment to the first remission	up to approximately 3 years

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Zhejiang Cancer Hospital; Changhai Hospital; Shanxi Province Cancer Hospital; Sun Yat-sen University; Peking Union Medical College Hospital; Fujian Cancer Hospital; Henan Cancer Hospital; Shanghai 10th People's Hospital; Ruijin Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Tianjin Medical University Cancer Institute and Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Jiangsu Cancer Institute & Hospital; Hunan Provincial People's Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Sir Run Run Shaw Hospital; The Affiliated Hospital of Inner Mongolia Medical University; Shanghai 6th People's Hospital; Liaoning Cancer Hospital & Institute; The Third Affiliated Hospital of Soochow University; The First Affiliated Hospital of Anhui University of Chinese Medicine; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Dalian Friendship Hospital Affiliated to Dalian Medical University
• Investigators: Principal Investigator: Dongmei Ji, M.D, Fudan University; Principal Investigator: Qinghai Ji, M.D, Fudan University; Principal Investigator: Yu Wang, M.D, Fudan University; Principal Investigator: Yansong Lin, M.D, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 23, 2023
• First Submitted That Met QC Criteria: December 23, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 9, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Pralsetinib; Entrectinib; Trametinib; Dabrafenib; Antibodies; Immunoglobulins; Lenvatinib
• Other Study ID Numbers: FUSCC-TC-RWS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No