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

NCT ID: NCT06195228

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2028-12-31

Brief Summary

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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

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see:Arms and Interventions

Conditions

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Advanced Thyroid Cancer Patients Who Received Target Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Radioiodine-refractory differentiated thyroid cancer

advanced or metastatic thyroid cancer patients who are refractory to radioiodine treatment

Group Type EXPERIMENTAL

dabrafenib plus trametinib with or without PD-1 antibody

Intervention Type DRUG

advanced thyroid cancer patients who harbor BRAF V600E mutation

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

Intervention Type DRUG

advanced thyroid cancer patients who harbor NTRK mutation

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

dabrafenib plus trametinib with or without PD-1 antibody

Intervention Type DRUG

advanced thyroid cancer patients who harbor BRAF V600E mutation

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

Intervention Type DRUG

advanced thyroid cancer patients who harbor NTRK mutation

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

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

Medullary thyroid cancer

patients with advanced or metastatic medullary thyroid cancer

Group Type EXPERIMENTAL

dabrafenib plus trametinib with or without PD-1 antibody

Intervention Type DRUG

advanced thyroid cancer patients who harbor BRAF V600E mutation

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

Intervention Type DRUG

advanced thyroid cancer patients who harbor NTRK mutation

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

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

High-grade or poorly differentiated thyroid cancer

patients with advanced or metastatic High-grade or poorly differentiated thyroid cancer

Group Type EXPERIMENTAL

dabrafenib plus trametinib with or without PD-1 antibody

Intervention Type DRUG

advanced thyroid cancer patients who harbor BRAF V600E mutation

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

Intervention Type DRUG

advanced thyroid cancer patients who harbor NTRK mutation

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

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

Anaplastic thyroid cancer

patients with anaplastic thyroid cancer

Group Type EXPERIMENTAL

dabrafenib plus trametinib with or without PD-1 antibody

Intervention Type DRUG

advanced thyroid cancer patients who harbor BRAF V600E mutation

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

Intervention Type DRUG

advanced thyroid cancer patients who harbor NTRK mutation

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

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

Interventions

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dabrafenib plus trametinib with or without PD-1 antibody

advanced thyroid cancer patients who harbor BRAF V600E mutation

Intervention Type DRUG

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

advanced thyroid cancer patients who harbor NTRK mutation

Intervention Type 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.

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Targets: precise treatment based on the target

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

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui University of Chinese Medicine

OTHER

Sponsor Role collaborator

Hunan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Dalian Friendship Hospital Affiliated to Dalian Medical University

UNKNOWN

Sponsor Role collaborator

The Third Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ji Dongmei

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dongmei Ji, M.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Yu Wang, M.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Qinghai Ji, M.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Yansong Lin, M.D

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Caixia Liu

Hohhot, Inner Mongolia, China

Site Status RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanxi Cancer Hospital

Shanxi, Taiyuan, China

Site Status RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Peking union medical college hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongmei Ji, M.D

Role: CONTACT

021-64175590 ext. 83650

Facility Contacts

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Yu Wu, M.D

Role: primary

13705003480

Jianwu Qin, M.D

Role: primary

13598802366

Wei Cao, M.D

Role: primary

13995658573

Caixia Liu, M.D

Role: primary

18847189559

M.D

Role: backup

Dongmei Ji, M.D

Role: primary

+8602164175590 ext. 73546

Linzi Jia, M.D

Role: primary

15035162908

Meiyu Fang, M.D

Role: primary

13750851650

Liang Guo

Role: backup

Yansong Lin, M.D.

Role: primary

(010)69156699

Other Identifiers

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FUSCC-TC-RWS01

Identifier Type: -

Identifier Source: org_study_id

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